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FDA 510(k)

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)

K-Number: K952873 · 1995-09-08

ApplicantMedix Biotech, Inc.
Decision Date1995-09-08
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K952873. 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 MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)?

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K952873.

When did MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) receive FDA 510(k) clearance?

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) received FDA 510(k) clearance on 1995-09-08, under 510(k) number K952873.

Who is the listed applicant for MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)?

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

What is the FDA product code for MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)?

The FDA product code for MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) is GTZ.

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Other records listing Medix Biotech, 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.

K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100K922047IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

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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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