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FDA 510(k)

MUREX SUDS GROUP A STREP

K-Number: K860576 · 1986-04-04

ApplicantMurex Corp.
Decision Date1986-04-04
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUREX SUDS GROUP A STREP is the device name listed in this FDA 510(k) record. The listed applicant is Murex Corp.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K860576. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUREX SUDS GROUP A STREP?

MUREX SUDS GROUP A STREP is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Murex Corp.. The 510(k) number is K860576.

When did MUREX SUDS GROUP A STREP receive FDA 510(k) clearance?

MUREX SUDS GROUP A STREP received FDA 510(k) clearance on 1986-04-04, under 510(k) number K860576.

Who is the listed applicant for MUREX SUDS GROUP A STREP?

The FDA 510(k) record lists Murex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MUREX SUDS GROUP A STREP?

The FDA product code for MUREX SUDS GROUP A STREP is GTZ.

Related Clinical Trials

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.

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Other records listing Murex Corp. 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.

K862048SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUMK861282MUREX SUDS RUBELLAK861458MUREX SUDS TOXOK860451MUREX (TM), SUDS (TM), HCG ASSAY

Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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