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FDA 510(k)

AIA-PACK(R) PROG ASSAY

K-Number: K933269 · 1993-10-22

ApplicantTosoh Medics, Inc.
Decision Date1993-10-22
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK(R) PROG 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 1993-10-22 under 510(k) number K933269. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK(R) PROG ASSAY?

AIA-PACK(R) PROG ASSAY is a medical device that received FDA 510(k) clearance on 1993-10-22. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K933269.

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

AIA-PACK(R) PROG ASSAY received FDA 510(k) clearance on 1993-10-22, under 510(k) number K933269.

Who is the listed applicant for AIA-PACK(R) PROG 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(R) PROG ASSAY?

The FDA product code for AIA-PACK(R) PROG ASSAY is JLS.

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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 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: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, 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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