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FDA 510(k)

TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA

K-Number: K971779 · 1997-06-16

ApplicantMonobind
Decision Date1997-06-16
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K971779. 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 TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA?

TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Monobind. The 510(k) number is K971779.

When did TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA receive FDA 510(k) clearance?

TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA received FDA 510(k) clearance on 1997-06-16, under 510(k) number K971779.

Who is the listed applicant for TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA?

The FDA 510(k) record lists Monobind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA?

The FDA product code for TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA is CDP.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

View all 21 devices →

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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