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FDA 510(k)

AIA-PACK FT3 ASSAY

K-Number: K991252 · 1999-05-11

ApplicantTosoh Medics, Inc.
Decision Date1999-05-11
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK FT3 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 1999-05-11 under 510(k) number K991252. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK FT3 ASSAY?

AIA-PACK FT3 ASSAY is a medical device that received FDA 510(k) clearance on 1999-05-11. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K991252.

When did AIA-PACK FT3 ASSAY receive FDA 510(k) clearance?

AIA-PACK FT3 ASSAY received FDA 510(k) clearance on 1999-05-11, under 510(k) number K991252.

Who is the listed applicant for AIA-PACK FT3 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 FT3 ASSAY?

The FDA product code for AIA-PACK FT3 ASSAY is CDP.

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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 IMMUNOASSAYK023894ST AIA-PACK AFP ENZYME IMMUNOASSAYK023091ST AIA-PACK TESTOSTERONE ASSAYK023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYK020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEK012820AIA-PACK CTNI 2ND-GEN ASSAY

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott LaboratoriesK983434ABBOTT ARCHITECT TOTAL T3Abbott Laboratories

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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