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FDA 510(k)

SRI T3 IMMOENZYMETRIC ASSAY

K-Number: K910737 · 1991-05-01

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-05-01
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI T3 IMMOENZYMETRIC ASSAY 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 1991-05-01 under 510(k) number K910737. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SRI T3 IMMOENZYMETRIC ASSAY?

SRI T3 IMMOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1991-05-01. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K910737.

When did SRI T3 IMMOENZYMETRIC ASSAY receive FDA 510(k) clearance?

SRI T3 IMMOENZYMETRIC ASSAY received FDA 510(k) clearance on 1991-05-01, under 510(k) number K910737.

Who is the listed applicant for SRI T3 IMMOENZYMETRIC ASSAY?

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 SRI T3 IMMOENZYMETRIC ASSAY?

The FDA product code for SRI T3 IMMOENZYMETRIC ASSAY is CDP.

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Other records listing Serono-Baker Diagnostics, 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.

K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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