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FDA 510(k)

ELEGANCE GH ELISA

K-Number: K905098 · 1990-12-06

ApplicantBioclone Australia Pty , Ltd.
Decision Date1990-12-06
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELEGANCE GH ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Bioclone Australia Pty , Ltd.. It received FDA 510(k) clearance on 1990-12-06 under 510(k) number K905098. 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 ELEGANCE GH ELISA?

ELEGANCE GH ELISA is a medical device that received FDA 510(k) clearance on 1990-12-06. The listed applicant is Bioclone Australia Pty , Ltd.. The 510(k) number is K905098.

When did ELEGANCE GH ELISA receive FDA 510(k) clearance?

ELEGANCE GH ELISA received FDA 510(k) clearance on 1990-12-06, under 510(k) number K905098.

Who is the listed applicant for ELEGANCE GH ELISA?

The FDA 510(k) record lists Bioclone Australia Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEGANCE GH ELISA?

The FDA product code for ELEGANCE GH ELISA is CFL.

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Other records listing Bioclone Australia Pty , Ltd. 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.

K935049ELEGANCE NEONATAL TSH ELISAK922284ELEGANCE FT4 ELISAK910419BIOCLONE'S ELEGANCE IGE ELISA KITK910420BIOCLONE'S ELEGANCE HCG ELISA KITK905099ELEGANCE TSH ELISAK904822ELEGANCE FERRITIN ELISA

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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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