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FDA 510(k)

AIA-PACK CPR ASSAY

K-Number: K951848 · 1996-02-13

ApplicantTosoh Medics, Inc.
Decision Date1996-02-13
Product CodeJKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK CPR 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 1996-02-13 under 510(k) number K951848. The device is classified under product code JKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK CPR ASSAY?

AIA-PACK CPR ASSAY is a medical device that received FDA 510(k) clearance on 1996-02-13. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K951848.

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

AIA-PACK CPR ASSAY received FDA 510(k) clearance on 1996-02-13, under 510(k) number K951848.

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

The FDA product code for AIA-PACK CPR ASSAY is JKD.

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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: JKD)

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.

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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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