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FDA 510(k)

GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY

K-Number: K812227 · 1981-09-24

ApplicantClinical Assays, Inc.
Decision Date1981-09-24
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812227. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY?

GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K812227.

When did GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY receive FDA 510(k) clearance?

GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812227.

Who is the listed applicant for GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY?

The FDA 510(k) record lists Clinical Assays, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY?

The FDA product code for GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY is CFP.

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Other records listing Clinical Assays, 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.

K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832711VITAMIN B12 FOLATE CA-1515-125K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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Related Devices (Code: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.

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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