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FDA 510(k)

HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT

K-Number: K851259 · 1985-05-13

ApplicantNichols Institute Diagnostics
Decision Date1985-05-13
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1985-05-13 under 510(k) number K851259. 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 HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT?

HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-05-13. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K851259.

When did HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT receive FDA 510(k) clearance?

HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT received FDA 510(k) clearance on 1985-05-13, under 510(k) number K851259.

Who is the listed applicant for HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT?

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

What is the FDA product code for HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT?

The FDA product code for HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT is CFL.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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