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FDA 510(k)

COAT-A-COUNT FREE THYROXINE KIT/COMPONEN

K-Number: K822882 · 1982-11-05

ApplicantDiagnostic Products Corp.
Decision Date1982-11-05
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT FREE THYROXINE KIT/COMPONEN 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 1982-11-05 under 510(k) number K822882. 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 COAT-A-COUNT FREE THYROXINE KIT/COMPONEN?

COAT-A-COUNT FREE THYROXINE KIT/COMPONEN is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K822882.

When did COAT-A-COUNT FREE THYROXINE KIT/COMPONEN receive FDA 510(k) clearance?

COAT-A-COUNT FREE THYROXINE KIT/COMPONEN received FDA 510(k) clearance on 1982-11-05, under 510(k) number K822882.

Who is the listed applicant for COAT-A-COUNT FREE THYROXINE KIT/COMPONEN?

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 THYROXINE KIT/COMPONEN?

The FDA product code for COAT-A-COUNT FREE THYROXINE KIT/COMPONEN is CEC.

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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: 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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