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FDA 510(k)

PHASE THYROXINE RADIOIMMUNOASSAY KIT

K-Number: K830642 · 1983-04-05

ApplicantMedical & Scientific Designs, Inc.
Decision Date1983-04-05
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHASE THYROXINE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830642. 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 PHASE THYROXINE RADIOIMMUNOASSAY KIT?

PHASE THYROXINE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K830642.

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

PHASE THYROXINE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830642.

Who is the listed applicant for PHASE THYROXINE RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE THYROXINE RADIOIMMUNOASSAY KIT?

The FDA product code for PHASE THYROXINE RADIOIMMUNOASSAY KIT is CDX.

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Other records listing Medical & Scientific Designs, Inc. 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.

K862960PHASE II FERRITIN RADIOIMMUNOASSAY KITK853224PHASE II B-12/FOLATE KITK840901PHASE II FREE T4 KITK840328PHASE II HCG KITK834219PHASE II CORTISOL KITK833789PHASE II THEOPHYLLINE RADIOIMMUNOASSAY

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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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