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FDA 510(k)

COAT-A-COUNT FREE T3 RIA KIT

K-Number: K832164 · 1983-10-27

ApplicantDiagnostic Products Corp.
Decision Date1983-10-27
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT FREE T3 RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1983-10-27 under 510(k) number K832164. 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 COAT-A-COUNT FREE T3 RIA KIT?

COAT-A-COUNT FREE T3 RIA KIT is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K832164.

When did COAT-A-COUNT FREE T3 RIA KIT receive FDA 510(k) clearance?

COAT-A-COUNT FREE T3 RIA KIT received FDA 510(k) clearance on 1983-10-27, under 510(k) number K832164.

Who is the listed applicant for COAT-A-COUNT FREE T3 RIA KIT?

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

What is the FDA product code for COAT-A-COUNT FREE T3 RIA KIT?

The FDA product code for COAT-A-COUNT FREE T3 RIA KIT is CDP.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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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.K983434ABBOTT ARCHITECT TOTAL 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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