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FDA 510(k)

SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT

K-Number: K926090 · 1993-09-30

ApplicantSyva Co.
Decision Date1993-09-30
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1993-09-30 under 510(k) number K926090. 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(R) II CHLAMYDIA EIA BLOCK REAGENT?

SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT is a medical device that received FDA 510(k) clearance on 1993-09-30. The listed applicant is Syva Co.. The 510(k) number is K926090.

When did SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT receive FDA 510(k) clearance?

SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT received FDA 510(k) clearance on 1993-09-30, under 510(k) number K926090.

Who is the listed applicant for SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT?

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(R) II CHLAMYDIA EIA BLOCK REAGENT?

The FDA product code for SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT 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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