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FDA 510(k)

SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION

K-Number: K905179 · 1991-03-12

ApplicantSyva Co.
Decision Date1991-03-12
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1991-03-12 under 510(k) number K905179. 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 SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION?

SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Syva Co.. The 510(k) number is K905179.

When did SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION receive FDA 510(k) clearance?

SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION received FDA 510(k) clearance on 1991-03-12, under 510(k) number K905179.

Who is the listed applicant for SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION?

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

What is the FDA product code for SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION?

The FDA product code for SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION is LJC.

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Other records listing Syva Co. as applicant

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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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