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FDA 510(k)

AIA-PACK HGH

K-Number: K905757 · 1991-01-25

ApplicantTosoh Medics, Inc.
Decision Date1991-01-25
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK HGH is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K905757. 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 AIA-PACK HGH?

AIA-PACK HGH is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K905757.

When did AIA-PACK HGH receive FDA 510(k) clearance?

AIA-PACK HGH received FDA 510(k) clearance on 1991-01-25, under 510(k) number K905757.

Who is the listed applicant for AIA-PACK HGH?

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

What is the FDA product code for AIA-PACK HGH?

The FDA product code for AIA-PACK HGH is CFL.

Other records listing Tosoh Medics, 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.

K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYK023091ST AIA-PACK TESTOSTERONE ASSAYK023894ST AIA-PACK AFP ENZYME IMMUNOASSAYK023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYK020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEK012820AIA-PACK CTNI 2ND-GEN ASSAY

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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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