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FDA 510(k)

ACTIVE IGF-I ELISA

K-Number: K951752 · 1995-05-10

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1995-05-10
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE IGF-I ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K951752. 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 ACTIVE IGF-I ELISA?

ACTIVE IGF-I ELISA is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K951752.

When did ACTIVE IGF-I ELISA receive FDA 510(k) clearance?

ACTIVE IGF-I ELISA received FDA 510(k) clearance on 1995-05-10, under 510(k) number K951752.

Who is the listed applicant for ACTIVE IGF-I ELISA?

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

What is the FDA product code for ACTIVE IGF-I ELISA?

The FDA product code for ACTIVE IGF-I ELISA is CFL.

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Other records listing Diagnostic Systems Laboratories, 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.

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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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