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FDA 510(k)

AIA-PACK TSH 3RD-GEN ASSAY

K-Number: K972586 · 1997-08-29

ApplicantTosoh Medics, Inc.
Decision Date1997-08-29
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK TSH 3RD-GEN ASSAY 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 1997-08-29 under 510(k) number K972586. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK TSH 3RD-GEN ASSAY?

AIA-PACK TSH 3RD-GEN ASSAY is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K972586.

When did AIA-PACK TSH 3RD-GEN ASSAY receive FDA 510(k) clearance?

AIA-PACK TSH 3RD-GEN ASSAY received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972586.

Who is the listed applicant for AIA-PACK TSH 3RD-GEN ASSAY?

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 TSH 3RD-GEN ASSAY?

The FDA product code for AIA-PACK TSH 3RD-GEN ASSAY is JLW.

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Other records listing Tosoh Medics, Inc. as applicant

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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: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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