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FDA 510(k)

AIA-PACK IRI

K-Number: K903628 · 1990-09-07

ApplicantTosoh Corp.
Decision Date1990-09-07
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK IRI is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Corp.. It received FDA 510(k) clearance on 1990-09-07 under 510(k) number K903628. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK IRI?

AIA-PACK IRI is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Tosoh Corp.. The 510(k) number is K903628.

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

AIA-PACK IRI received FDA 510(k) clearance on 1990-09-07, under 510(k) number K903628.

Who is the listed applicant for AIA-PACK IRI?

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 IRI?

The FDA product code for AIA-PACK IRI is CFP.

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-MBK913493AIA-PACK FT4

View all 11 devices →

Related Devices (Code: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.K896572REP(TM) SPE PLUS-30 PROCEDURESHelena 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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