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FDA 510(k)

FEBRILE ANTIGENS & CONTROL SERUMS

K-Number: K760097 · 1976-08-03

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

Device Summary

FEBRILE ANTIGENS & CONTROL SERUMS 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 K760097. The device is classified under product code GSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEBRILE ANTIGENS & CONTROL SERUMS?

FEBRILE ANTIGENS & CONTROL SERUMS 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 K760097.

When did FEBRILE ANTIGENS & CONTROL SERUMS receive FDA 510(k) clearance?

FEBRILE ANTIGENS & CONTROL SERUMS received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760097.

Who is the listed applicant for FEBRILE ANTIGENS & CONTROL SERUMS?

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 FEBRILE ANTIGENS & CONTROL SERUMS?

The FDA product code for FEBRILE ANTIGENS & CONTROL SERUMS is GSZ.

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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: GSZ)

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.

K885110PROTEUS OX-19 IFA*Investigacion Farmaceutica S.A. DE C.V.K760881FEBRILE ANTIGEN CONTROL SERABd Becton Dickinson Vacutainer Systems Preanalytic

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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