Resubmit Initial SDS microarray for FDA 510(k)
Not delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 1 Feb 2021
- Due
- 30 Jun 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“US FDA 510(k) resubmission is planned in Q2 CY2021”
What we found
Evidence strength A What the grades mean
The company did not resubmit the initial SDS microarray 510(k) by the Q2 2021 deadline, subsequently pushing the anticipated resubmission date to the end of 2021.
-
A Quotient Ltd 10-Q filed 2021-08-05
“We anticipate that we will resubmit our filing for 510(k) clearance for the initial MosaiQ SDS Microarray around year-end of calendar year 2021.” ✓ confirmed on the page
Checked 25 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Resubmit
- Deliverable
- FDA 510(k) resubmission
- Where
- United States
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
- Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
Are you Quotient Ltd? You can publish an official statement next to this entry, free. Add a statement.
Is something here wrong or out of date? Companies and readers can ask us to check it. Please bring a link to a public source.
Report an error in this entry Reference: KI-C-2021-C596946-022763 · Corrections policy