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FDA 510(k)

REDITEST STREP A TEST KIT

K-Number: K903194 · 1990-08-22

ApplicantBoehringer Mannheim Corp.
Decision Date1990-08-22
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REDITEST STREP A TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K903194. 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 REDITEST STREP A TEST KIT?

REDITEST STREP A TEST KIT is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K903194.

When did REDITEST STREP A TEST KIT receive FDA 510(k) clearance?

REDITEST STREP A TEST KIT received FDA 510(k) clearance on 1990-08-22, under 510(k) number K903194.

Who is the listed applicant for REDITEST STREP A TEST KIT?

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

What is the FDA product code for REDITEST STREP A TEST KIT?

The FDA product code for REDITEST STREP A TEST KIT is GTZ.

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Other records listing Boehringer Mannheim Corp. as applicant

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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

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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