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FDA 510(k)

DETECT-A-STREP

K-Number: K843590 · 1984-10-30

ApplicantAntibodies, Inc.
Decision Date1984-10-30
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DETECT-A-STREP is the device name listed in this FDA 510(k) record. The listed applicant is Antibodies, Inc.. It received FDA 510(k) clearance on 1984-10-30 under 510(k) number K843590. 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 DETECT-A-STREP?

DETECT-A-STREP is a medical device that received FDA 510(k) clearance on 1984-10-30. The listed applicant is Antibodies, Inc.. The 510(k) number is K843590.

When did DETECT-A-STREP receive FDA 510(k) clearance?

DETECT-A-STREP received FDA 510(k) clearance on 1984-10-30, under 510(k) number K843590.

Who is the listed applicant for DETECT-A-STREP?

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

What is the FDA product code for DETECT-A-STREP?

The FDA product code for DETECT-A-STREP is GTZ.

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Other records listing Antibodies, 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.

K890774GIARDEIA(TM)K822892CORTISOL RIA KITK812749ULTRA-DIGK812314CRITHIDNA ANTI-DNA TEST KITK802877AMIKACIN RIA KITK800743TOBRAMYCIN RIA KIT

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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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