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FDA 510(k)

MICRO TRAK CHLAMYDIA TRACHOMATIS CULT

K-Number: K823010 · 1982-12-15

ApplicantSyva Co.
Decision Date1982-12-15
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICRO TRAK CHLAMYDIA TRACHOMATIS CULT is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823010. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO TRAK CHLAMYDIA TRACHOMATIS CULT?

MICRO TRAK CHLAMYDIA TRACHOMATIS CULT is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Syva Co.. The 510(k) number is K823010.

When did MICRO TRAK CHLAMYDIA TRACHOMATIS CULT receive FDA 510(k) clearance?

MICRO TRAK CHLAMYDIA TRACHOMATIS CULT received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823010.

Who is the listed applicant for MICRO TRAK CHLAMYDIA TRACHOMATIS CULT?

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 MICRO TRAK CHLAMYDIA TRACHOMATIS CULT?

The FDA product code for MICRO TRAK CHLAMYDIA TRACHOMATIS CULT is LJP.

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Other records listing Syva Co. as applicant

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Related Devices (Code: LJP)

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.

K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITDiagnostic Hybrids, Inc.K941714CHLAMYDIA TRACHOMATIS ANTIGEN TESTNeogenexK901243CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TESTCel Labs Pty, Ltd.K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTDiagnostic Products Corp.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, 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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