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FDA 510(k)

CARDS(TM) STREP A CATALOG NO. CR-7545

K-Number: K863647 · 1986-11-26

ApplicantPacific Biotech, Inc.
Decision Date1986-11-26
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CARDS(TM) STREP A CATALOG NO. CR-7545 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 1986-11-26 under 510(k) number K863647. 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(TM) STREP A CATALOG NO. CR-7545?

CARDS(TM) STREP A CATALOG NO. CR-7545 is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K863647.

When did CARDS(TM) STREP A CATALOG NO. CR-7545 receive FDA 510(k) clearance?

CARDS(TM) STREP A CATALOG NO. CR-7545 received FDA 510(k) clearance on 1986-11-26, under 510(k) number K863647.

Who is the listed applicant for CARDS(TM) STREP A CATALOG NO. CR-7545?

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(TM) STREP A CATALOG NO. CR-7545?

The FDA product code for CARDS(TM) STREP A CATALOG NO. CR-7545 is GTZ.

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Other records listing Pacific Biotech, Inc. as applicant

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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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