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FDA 510(k)

STREPTEX ACID EXTRACTION KIT

K-Number: K910797 · 1991-03-29

ApplicantWellcome Diagnostics
Decision Date1991-03-29
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTEX ACID EXTRACTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910797. 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 STREPTEX ACID EXTRACTION KIT?

STREPTEX ACID EXTRACTION KIT is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Wellcome Diagnostics. The 510(k) number is K910797.

When did STREPTEX ACID EXTRACTION KIT receive FDA 510(k) clearance?

STREPTEX ACID EXTRACTION KIT received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910797.

Who is the listed applicant for STREPTEX ACID EXTRACTION KIT?

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

What is the FDA product code for STREPTEX ACID EXTRACTION KIT?

The FDA product code for STREPTEX ACID EXTRACTION KIT is GTZ.

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Other records listing Wellcome Diagnostics 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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