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FDA 510(k)

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST

K-Number: K870946 · 1987-04-29

ApplicantSerono Diagnostics, Inc.
Decision Date1987-04-29
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-29 under 510(k) number K870946. 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 MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST?

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST is a medical device that received FDA 510(k) clearance on 1987-04-29. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K870946.

When did MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST receive FDA 510(k) clearance?

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST received FDA 510(k) clearance on 1987-04-29, under 510(k) number K870946.

Who is the listed applicant for MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST?

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

What is the FDA product code for MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST?

The FDA product code for MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST is LJP.

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Other records listing Serono Diagnostics, 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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