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FDA 510(k)

SR1 FREE T4 ENZYME IMMUNOASSAY

K-Number: K912937 · 1991-11-19

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-11-19
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SR1 FREE T4 ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K912937. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SR1 FREE T4 ENZYME IMMUNOASSAY?

SR1 FREE T4 ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K912937.

When did SR1 FREE T4 ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

SR1 FREE T4 ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1991-11-19, under 510(k) number K912937.

Who is the listed applicant for SR1 FREE T4 ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Serono-Baker Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR1 FREE T4 ENZYME IMMUNOASSAY?

The FDA product code for SR1 FREE T4 ENZYME IMMUNOASSAY is CEC.

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Other records listing Serono-Baker Diagnostics, Inc. as applicant

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K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)K911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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