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FDA 510(k)

TEST, STREP, LATEX SLIDE

K-Number: K760034 · 1976-08-11

ApplicantGamma Biologicals, Inc.
Decision Date1976-08-11
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST, STREP, 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 1976-08-11 under 510(k) number K760034. The device is classified under product code DEM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST, STREP, LATEX SLIDE?

TEST, STREP, LATEX SLIDE is a medical device that received FDA 510(k) clearance on 1976-08-11. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K760034.

When did TEST, STREP, LATEX SLIDE receive FDA 510(k) clearance?

TEST, STREP, LATEX SLIDE received FDA 510(k) clearance on 1976-08-11, under 510(k) number K760034.

Who is the listed applicant for TEST, STREP, 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, STREP, LATEX SLIDE?

The FDA product code for TEST, STREP, LATEX SLIDE is DEM.

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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: DEM)

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.

K123256HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSThe Binding Site Group , Ltd.K063610DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K053072N ANTISERA TO HUMAN ALPHA1-ANTITRYPSINDade Behring, Inc.K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K050596QUANTIA A1-ATBiokit, S.A.K031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.

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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