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FDA 510(k)

CARDS O.S.(TM) STREP A

K-Number: K896221 · 1989-12-13

ApplicantPacific Biotech, Inc.
Decision Date1989-12-13
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CARDS O.S.(TM) STREP A is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K896221. 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 CARDS O.S.(TM) STREP A?

CARDS O.S.(TM) STREP A is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K896221.

When did CARDS O.S.(TM) STREP A receive FDA 510(k) clearance?

CARDS O.S.(TM) STREP A received FDA 510(k) clearance on 1989-12-13, under 510(k) number K896221.

Who is the listed applicant for CARDS O.S.(TM) STREP A?

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

What is the FDA product code for CARDS O.S.(TM) STREP A?

The FDA product code for CARDS O.S.(TM) STREP A is GTZ.

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Other records listing Pacific 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.

K924461STREP A NEGATIVE CONTROLK902510CARDS O.S. MONOK896482PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KITK895390CARDS O.S. (TM) HCG-URINEK891770HCG IRMA IIK884616FIRSTDAY EARLY PREGNANCY TESTING KIT II

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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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