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FDA 510(k)

VENTRESIGN STREP A TEST

K-Number: K897083 · 1990-01-22

ApplicantVentrex Laboratories, Inc.
Decision Date1990-01-22
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VENTRESIGN STREP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K897083. 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 VENTRESIGN STREP A TEST?

VENTRESIGN STREP A TEST is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K897083.

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

VENTRESIGN STREP A TEST received FDA 510(k) clearance on 1990-01-22, under 510(k) number K897083.

Who is the listed applicant for VENTRESIGN STREP A TEST?

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

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

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

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Other records listing Ventrex Laboratories, 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.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA 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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