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FDA 510(k)

STREP A QUICK

K-Number: K850831 · 1985-04-08

ApplicantAbbott Laboratories
Decision Date1985-04-08
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP A QUICK is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850831. 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 STREP A QUICK?

STREP A QUICK is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Abbott Laboratories. The 510(k) number is K850831.

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

STREP A QUICK received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850831.

Who is the listed applicant for STREP A QUICK?

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

What is the FDA product code for STREP A QUICK?

The FDA product code for STREP A QUICK 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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