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FDA 510(k)

BACTIGEN(R) GROUP B STREPTOCOCCUS TEST

K-Number: K885003 · 1989-02-07

ApplicantArmkel, LLC
Decision Date1989-02-07
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIGEN(R) GROUP B STREPTOCOCCUS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K885003. 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 BACTIGEN(R) GROUP B STREPTOCOCCUS TEST?

BACTIGEN(R) GROUP B STREPTOCOCCUS TEST is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Armkel, LLC. The 510(k) number is K885003.

When did BACTIGEN(R) GROUP B STREPTOCOCCUS TEST receive FDA 510(k) clearance?

BACTIGEN(R) GROUP B STREPTOCOCCUS TEST received FDA 510(k) clearance on 1989-02-07, under 510(k) number K885003.

Who is the listed applicant for BACTIGEN(R) GROUP B STREPTOCOCCUS TEST?

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

What is the FDA product code for BACTIGEN(R) GROUP B STREPTOCOCCUS TEST?

The FDA product code for BACTIGEN(R) GROUP B STREPTOCOCCUS TEST is GTZ.

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Other records listing Armkel, LLC 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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