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FDA 510(k)

RIA-QUANT CK-MB TEST KIT

K-Number: K792504 · 1980-01-16

ApplicantMallinckrodt Critical Care
Decision Date1980-01-16
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA-QUANT CK-MB TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792504. 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 RIA-QUANT CK-MB TEST KIT?

RIA-QUANT CK-MB TEST KIT is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K792504.

When did RIA-QUANT CK-MB TEST KIT receive FDA 510(k) clearance?

RIA-QUANT CK-MB TEST KIT received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792504.

Who is the listed applicant for RIA-QUANT CK-MB TEST KIT?

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

What is the FDA product code for RIA-QUANT CK-MB TEST KIT?

The FDA product code for RIA-QUANT CK-MB TEST KIT is JHX.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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