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FDA 510(k)

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE

K-Number: K760033 · 1976-08-03

ApplicantGamma Biologicals, Inc.
Decision Date1976-08-03
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760033. 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 TEST, ANTIBODIES FOR GRP A, LATEX SLIDE?

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K760033.

When did TEST, ANTIBODIES FOR GRP A, LATEX SLIDE receive FDA 510(k) clearance?

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760033.

Who is the listed applicant for TEST, ANTIBODIES FOR GRP A, LATEX SLIDE?

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

What is the FDA product code for TEST, ANTIBODIES FOR GRP A, LATEX SLIDE?

The FDA product code for TEST, ANTIBODIES FOR GRP A, LATEX SLIDE is GTZ.

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Other records listing Gamma Biologicals, 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.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUS

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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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