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FDA 510(k)

SOMATOMEDIN C BY RADIOIMMUNOASSAY

K-Number: K850892 · 1985-06-06

ApplicantImmuno Nuclear Corp.
Decision Date1985-06-06
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOMATOMEDIN C BY RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Nuclear Corp.. It received FDA 510(k) clearance on 1985-06-06 under 510(k) number K850892. The device is classified under product code CFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMATOMEDIN C BY RADIOIMMUNOASSAY?

SOMATOMEDIN C BY RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1985-06-06. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K850892.

When did SOMATOMEDIN C BY RADIOIMMUNOASSAY receive FDA 510(k) clearance?

SOMATOMEDIN C BY RADIOIMMUNOASSAY received FDA 510(k) clearance on 1985-06-06, under 510(k) number K850892.

Who is the listed applicant for SOMATOMEDIN C BY RADIOIMMUNOASSAY?

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

What is the FDA product code for SOMATOMEDIN C BY RADIOIMMUNOASSAY?

The FDA product code for SOMATOMEDIN C BY RADIOIMMUNOASSAY is CFL.

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Related Devices (Code: CFL)

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K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.K971353DSL ACTIVE NON-EXTRACTION IGF-I ELISADiagnostic Systems Laboratories, Inc.K970701DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)Diagnostic Systems Laboratories, Inc.K962758DSL 9100 IGF-II IRMADiagnostic Systems Laboratories, Inc.K961678HUMAN GROWTH HORMONE IMMUNOASSAY KITNichols Institute DiagnosticsK961172DSL ACTIVE NON-EXTRACTION IGF-I IRMADiagnostic Systems Laboratories, 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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