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FDA 510(k)

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT

K-Number: K915235 · 1992-01-28

ApplicantIncstar Corp.
Decision Date1992-01-28
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1992-01-28 under 510(k) number K915235. 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 CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT?

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT is a medical device that received FDA 510(k) clearance on 1992-01-28. The listed applicant is Incstar Corp.. The 510(k) number is K915235.

When did CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT receive FDA 510(k) clearance?

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT received FDA 510(k) clearance on 1992-01-28, under 510(k) number K915235.

Who is the listed applicant for CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT?

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

What is the FDA product code for CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT?

The FDA product code for CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT is CDX.

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Other records listing Incstar 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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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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