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FDA 510(k)

CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC

K-Number: K831962 · 1983-10-05

ApplicantAbbott Laboratories
Decision Date1983-10-05
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-10-05 under 510(k) number K831962. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC?

CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC is a medical device that received FDA 510(k) clearance on 1983-10-05. The listed applicant is Abbott Laboratories. The 510(k) number is K831962.

When did CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC receive FDA 510(k) clearance?

CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC received FDA 510(k) clearance on 1983-10-05, under 510(k) number K831962.

Who is the listed applicant for CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC?

The FDA product code for CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC is LJC.

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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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