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FDA 510(k)

FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI

K-Number: K883352 · 1988-10-06

ApplicantWhittaker Bioproducts, Inc.
Decision Date1988-10-06
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K883352. 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 FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI?

FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K883352.

When did FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI receive FDA 510(k) clearance?

FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI received FDA 510(k) clearance on 1988-10-06, under 510(k) number K883352.

Who is the listed applicant for FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI?

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

What is the FDA product code for FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI?

The FDA product code for FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI is LJP.

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Other records listing Whittaker Bioproducts, 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.K881500ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TESTOrtho Diagnostic Systems, 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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