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FDA 510(k)

TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT

K-Number: K780787 · 1978-06-06

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1978-06-06
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT 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 1978-06-06 under 510(k) number K780787. 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 TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT?

TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K780787.

When did TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780787.

Who is the listed applicant for TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT?

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 TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT?

The FDA product code for TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT is CDP.

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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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