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FDA 510(k)

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY

K-Number: K972761 · 1997-09-25

ApplicantSealite Sciences, Inc.
Decision Date1997-09-25
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sealite Sciences, Inc.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K972761. 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 SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY?

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K972761.

When did SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY receive FDA 510(k) clearance?

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY received FDA 510(k) clearance on 1997-09-25, under 510(k) number K972761.

Who is the listed applicant for SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY?

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

What is the FDA product code for SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY?

The FDA product code for SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY is CFL.

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Other records listing Sealite Sciences, 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.

K974551SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAYK970612SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAYK970483AQUALITE INTACT PTHK970188SEALITE SCIENCES, INC. AQUALITE PROLACTINK970085SEALITE SCIENCES AQUALITE FSHK964925SEALITE SCIENCES, INC. AQUALITE LH

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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.

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.K960551DSL ACTIVE HUMAN GROWTH HORMONE ELISADiagnostic 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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