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FDA 510(k)

DSL 9100 IGF-II IRMA

K-Number: K962758 · 1996-08-30

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1996-08-30
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL 9100 IGF-II IRMA 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 1996-08-30 under 510(k) number K962758. 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 DSL 9100 IGF-II IRMA?

DSL 9100 IGF-II IRMA is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K962758.

When did DSL 9100 IGF-II IRMA receive FDA 510(k) clearance?

DSL 9100 IGF-II IRMA received FDA 510(k) clearance on 1996-08-30, under 510(k) number K962758.

Who is the listed applicant for DSL 9100 IGF-II IRMA?

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 DSL 9100 IGF-II IRMA?

The FDA product code for DSL 9100 IGF-II IRMA is CFL.

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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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.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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