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FDA 510(k)

IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3

K-Number: K946247 · 1995-06-23

ApplicantNichols Institute
Decision Date1995-06-23
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1995-06-23 under 510(k) number K946247. 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 IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3?

IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 is a medical device that received FDA 510(k) clearance on 1995-06-23. The listed applicant is Nichols Institute. The 510(k) number is K946247.

When did IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 receive FDA 510(k) clearance?

IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 received FDA 510(k) clearance on 1995-06-23, under 510(k) number K946247.

Who is the listed applicant for IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3?

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 IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3?

The FDA product code for IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 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 KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K950524NICHOLS 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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