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FDA 510(k)

AIA-PACK FT4

K-Number: K913493 · 1991-09-10

ApplicantTosoh Corp.
Decision Date1991-09-10
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK FT4 is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Corp.. It received FDA 510(k) clearance on 1991-09-10 under 510(k) number K913493. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK FT4?

AIA-PACK FT4 is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Tosoh Corp.. The 510(k) number is K913493.

When did AIA-PACK FT4 receive FDA 510(k) clearance?

AIA-PACK FT4 received FDA 510(k) clearance on 1991-09-10, under 510(k) number K913493.

Who is the listed applicant for AIA-PACK FT4?

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

What is the FDA product code for AIA-PACK FT4?

The FDA product code for AIA-PACK FT4 is CEC.

Other records listing Tosoh Corp. 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.

K023239AIA-PACK CA 19-9K023240ST AIA-PACK CA 19-9K923021AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEMK913663AIA-PACK T-UK913298AIA-PACK CK-MBK903628AIA-PACK IRI

View all 11 devices →

Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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