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FDA 510(k)

OCTEIA IGF-1 KIT

K-Number: K950510 · 1995-04-05

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date1995-04-05
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OCTEIA IGF-1 KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K950510. 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 OCTEIA IGF-1 KIT?

OCTEIA IGF-1 KIT is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K950510.

When did OCTEIA IGF-1 KIT receive FDA 510(k) clearance?

OCTEIA IGF-1 KIT received FDA 510(k) clearance on 1995-04-05, under 510(k) number K950510.

Who is the listed applicant for OCTEIA IGF-1 KIT?

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

What is the FDA product code for OCTEIA IGF-1 KIT?

The FDA product code for OCTEIA IGF-1 KIT is CFL.

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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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