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FDA 510(k)

IMMUNOCARD STREP A TEST

K-Number: K896109 · 1989-11-29

ApplicantDisease Detection International, Inc.
Decision Date1989-11-29
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD STREP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K896109. 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 IMMUNOCARD STREP A TEST?

IMMUNOCARD STREP A TEST is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K896109.

When did IMMUNOCARD STREP A TEST receive FDA 510(k) clearance?

IMMUNOCARD STREP A TEST received FDA 510(k) clearance on 1989-11-29, under 510(k) number K896109.

Who is the listed applicant for IMMUNOCARD STREP A TEST?

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

What is the FDA product code for IMMUNOCARD STREP A TEST?

The FDA product code for IMMUNOCARD STREP A TEST is GTZ.

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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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