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FDA 510(k)

COAT-A-COUNT NEONATAL T4 KIT RIA KIT

K-Number: K831107 · 1983-05-18

ApplicantDiagnostic Products Corp.
Decision Date1983-05-18
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT NEONATAL T4 KIT 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 1983-05-18 under 510(k) number K831107. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT NEONATAL T4 KIT RIA KIT?

COAT-A-COUNT NEONATAL T4 KIT RIA KIT is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K831107.

When did COAT-A-COUNT NEONATAL T4 KIT RIA KIT receive FDA 510(k) clearance?

COAT-A-COUNT NEONATAL T4 KIT RIA KIT received FDA 510(k) clearance on 1983-05-18, under 510(k) number K831107.

Who is the listed applicant for COAT-A-COUNT NEONATAL T4 KIT 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 NEONATAL T4 KIT RIA KIT?

The FDA product code for COAT-A-COUNT NEONATAL T4 KIT RIA KIT is CDX.

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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

View all 321 devices →

Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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