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FDA 510(k)

FEBRILE ANTIGEN CONTROL SERA

K-Number: K760881 · 1976-11-09

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1976-11-09
Product CodeGSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FEBRILE ANTIGEN CONTROL SERA is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1976-11-09 under 510(k) number K760881. 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 ANTIGEN CONTROL SERA?

FEBRILE ANTIGEN CONTROL SERA is a medical device that received FDA 510(k) clearance on 1976-11-09. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K760881.

When did FEBRILE ANTIGEN CONTROL SERA receive FDA 510(k) clearance?

FEBRILE ANTIGEN CONTROL SERA received FDA 510(k) clearance on 1976-11-09, under 510(k) number K760881.

Who is the listed applicant for FEBRILE ANTIGEN CONTROL SERA?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEBRILE ANTIGEN CONTROL SERA?

The FDA product code for FEBRILE ANTIGEN CONTROL SERA is GSZ.

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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.K760097FEBRILE ANTIGENS & CONTROL SERUMSGamma Biologicals, 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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