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FDA 510(k)

AIA-PACK CK-MB

K-Number: K913298 · 1991-09-27

ApplicantTosoh Corp.
Decision Date1991-09-27
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Corp.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K913298. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK CK-MB?

AIA-PACK CK-MB is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Tosoh Corp.. The 510(k) number is K913298.

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

AIA-PACK CK-MB received FDA 510(k) clearance on 1991-09-27, under 510(k) number K913298.

Who is the listed applicant for AIA-PACK CK-MB?

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 CK-MB?

The FDA product code for AIA-PACK CK-MB is JHX.

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-UK913493AIA-PACK FT4K903628AIA-PACK IRI

View all 11 devices →

Related Devices (Code: JHX)

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.

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical ApsK120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical ApsK081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku IatronK051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, 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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