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FDA 510(k)

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

K-Number: K082141 · 2008-09-03

ApplicantBiokit, S.A.
Decision Date2008-09-03
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2008-09-03 under 510(k) number K082141. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10?

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 is a medical device that received FDA 510(k) clearance on 2008-09-03. The listed applicant is Biokit, S.A.. The 510(k) number is K082141.

When did ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 receive FDA 510(k) clearance?

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 received FDA 510(k) clearance on 2008-09-03, under 510(k) number K082141.

Who is the listed applicant for ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10?

The FDA product code for ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 is JIT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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