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FDA 510(k)

DIAGNOSTIC REAGENT TST-RPLA

K-Number: K855236 · 1986-11-04

ApplicantOxoid U.S.A., Inc.
Decision Date1986-11-04
Product CodeGTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC REAGENT TST-RPLA is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1986-11-04 under 510(k) number K855236. The device is classified under product code GTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTIC REAGENT TST-RPLA?

DIAGNOSTIC REAGENT TST-RPLA is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K855236.

When did DIAGNOSTIC REAGENT TST-RPLA receive FDA 510(k) clearance?

DIAGNOSTIC REAGENT TST-RPLA received FDA 510(k) clearance on 1986-11-04, under 510(k) number K855236.

Who is the listed applicant for DIAGNOSTIC REAGENT TST-RPLA?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC REAGENT TST-RPLA?

The FDA product code for DIAGNOSTIC REAGENT TST-RPLA is GTN.

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Other records listing Oxoid U.S.A., Inc. as applicant

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.

K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819

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Related Devices (Code: GTN)

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.

K855233DIAGNOSTIC REAGENT SET-RPLAOxoid U.S.A., Inc.K851949STAPHAUREX ZL30Wellcome DiagnosticsK791453AGGLUTINOTEST-STAPHYLOLISINVolu Sol Medical Industries

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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