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FDA 510(k)

ANTIGENZ CHLAMYDIA

K-Number: K912680 · 1991-07-22

ApplicantBaxter Diagnostics, Inc.
Decision Date1991-07-22
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIGENZ CHLAMYDIA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K912680. 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 ANTIGENZ CHLAMYDIA?

ANTIGENZ CHLAMYDIA is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K912680.

When did ANTIGENZ CHLAMYDIA receive FDA 510(k) clearance?

ANTIGENZ CHLAMYDIA received FDA 510(k) clearance on 1991-07-22, under 510(k) number K912680.

Who is the listed applicant for ANTIGENZ CHLAMYDIA?

The FDA 510(k) record lists Baxter Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIGENZ CHLAMYDIA?

The FDA product code for ANTIGENZ CHLAMYDIA is LJC.

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Other records listing Baxter Diagnostics, Inc. as applicant

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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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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