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FDA 510(k)

ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT

K-Number: K871620 · 1987-06-17

ApplicantAllelix, Inc.
Decision Date1987-06-17
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Allelix, Inc.. It received FDA 510(k) clearance on 1987-06-17 under 510(k) number K871620. 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 ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT?

ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT is a medical device that received FDA 510(k) clearance on 1987-06-17. The listed applicant is Allelix, Inc.. The 510(k) number is K871620.

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

ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT received FDA 510(k) clearance on 1987-06-17, under 510(k) number K871620.

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

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

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

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

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Other records listing Allelix, 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.

K871308ALLELIX PREGNANCY DETECTION KIT 48 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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