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FDA 510(k)

INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)

K-Number: K952505 · 1995-07-03

ApplicantNichols Institute
Decision Date1995-07-03
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1995-07-03 under 510(k) number K952505. 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 INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)?

INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Nichols Institute. The 510(k) number is K952505.

When did INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) receive FDA 510(k) clearance?

INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) received FDA 510(k) clearance on 1995-07-03, under 510(k) number K952505.

Who is the listed applicant for INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)?

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

What is the FDA product code for INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)?

The FDA product code for INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) is CFL.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAYK931777APO A-1 CHEMILUMINESCENCE ASSAY

View all 15 devices →

Related Devices (Code: CFL)

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.

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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