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FDA 510(k)

CHLAMYDIA FLUORO-KIT 1680

K-Number: K850158 · 1985-03-21

ApplicantClinical Sciences, Inc.
Decision Date1985-03-21
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA FLUORO-KIT 1680 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1985-03-21 under 510(k) number K850158. 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 CHLAMYDIA FLUORO-KIT 1680?

CHLAMYDIA FLUORO-KIT 1680 is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K850158.

When did CHLAMYDIA FLUORO-KIT 1680 receive FDA 510(k) clearance?

CHLAMYDIA FLUORO-KIT 1680 received FDA 510(k) clearance on 1985-03-21, under 510(k) number K850158.

Who is the listed applicant for CHLAMYDIA FLUORO-KIT 1680?

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

What is the FDA product code for CHLAMYDIA FLUORO-KIT 1680?

The FDA product code for CHLAMYDIA FLUORO-KIT 1680 is LJP.

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Other records listing Clinical Sciences, Inc. 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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