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FDA 510(k)

RPR CARD TEST KIT

K-Number: K955136 · 1996-07-29

ApplicantRemel, L.P.
Decision Date1996-07-29
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RPR CARD TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Remel, L.P.. It received FDA 510(k) clearance on 1996-07-29 under 510(k) number K955136. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPR CARD TEST KIT?

RPR CARD TEST KIT is a medical device that received FDA 510(k) clearance on 1996-07-29. The listed applicant is Remel, L.P.. The 510(k) number is K955136.

When did RPR CARD TEST KIT receive FDA 510(k) clearance?

RPR CARD TEST KIT received FDA 510(k) clearance on 1996-07-29, under 510(k) number K955136.

Who is the listed applicant for RPR CARD TEST KIT?

The FDA 510(k) record lists Remel, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RPR CARD TEST KIT?

The FDA product code for RPR CARD TEST KIT is GMQ.

Other records listing Remel, L.P. 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.

K972359REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCINK964315REMEL STAPH LATEX KITK964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISKK96104610B ARGININE BROTHK955143RPR LIQUID CONTROLSK961818GENTAMICIN DISK (120MCG)

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Related Devices (Code: GMQ)

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.

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLCK201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi)K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)K000687THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTBeacon Biologicals, Inc.K993633SYNTHETIC VDRL ANTIGENCenters for Disease Control and Prevention

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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