Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10
FDA 510(k) K082141 · Biokit, S.A.
510(k) numberK082141
Submission
- Device name
- Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- July 30, 2008
- Decision date
- September 3, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10 cleared by the FDA?
Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10 (K082141) received a 510(k) decision of Substantially Equivalent on September 3, 2008, 35 days after the submission was received.
What is the product code of K082141?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.