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FDA 510(k)

CHLAMYDIAZYME DIAGNOSTIC KIT

K-Number: K900543 · 1990-05-03

ApplicantAbbott Laboratories
Decision Date1990-05-03
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIAZYME DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-05-03 under 510(k) number K900543. 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 DIAGNOSTIC KIT?

CHLAMYDIAZYME DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1990-05-03. The listed applicant is Abbott Laboratories. The 510(k) number is K900543.

When did CHLAMYDIAZYME DIAGNOSTIC KIT receive FDA 510(k) clearance?

CHLAMYDIAZYME DIAGNOSTIC KIT received FDA 510(k) clearance on 1990-05-03, under 510(k) number K900543.

Who is the listed applicant for CHLAMYDIAZYME DIAGNOSTIC KIT?

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 DIAGNOSTIC KIT?

The FDA product code for CHLAMYDIAZYME DIAGNOSTIC KIT is LJC.

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Related Devices (Code: LJC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.

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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