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FDA 510(k)

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT

K-Number: K880665 · 1988-03-01

ApplicantAllelix Diagnostics, Inc.
Decision Date1988-03-01
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Allelix Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-03-01 under 510(k) number K880665. 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 MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT?

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT is a medical device that received FDA 510(k) clearance on 1988-03-01. The listed applicant is Allelix Diagnostics, Inc.. The 510(k) number is K880665.

When did MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT receive FDA 510(k) clearance?

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT received FDA 510(k) clearance on 1988-03-01, under 510(k) number K880665.

Who is the listed applicant for MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT?

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

What is the FDA product code for MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT?

The FDA product code for MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT is GTZ.

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Other records listing Allelix Diagnostics, 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.

K885298VISUWELL REAGIN TEST 960 TEST KIT

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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