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FDA 510(k)

MYDAS(TM)-MB2/MYDAS(TM)-MB

K-Number: K913380 · 1992-04-22

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1992-04-22
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MYDAS(TM)-MB2/MYDAS(TM)-MB is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1992-04-22 under 510(k) number K913380. 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 MYDAS(TM)-MB2/MYDAS(TM)-MB?

MYDAS(TM)-MB2/MYDAS(TM)-MB is a medical device that received FDA 510(k) clearance on 1992-04-22. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K913380.

When did MYDAS(TM)-MB2/MYDAS(TM)-MB receive FDA 510(k) clearance?

MYDAS(TM)-MB2/MYDAS(TM)-MB received FDA 510(k) clearance on 1992-04-22, under 510(k) number K913380.

Who is the listed applicant for MYDAS(TM)-MB2/MYDAS(TM)-MB?

The FDA 510(k) record lists Intl. Immunoassay Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYDAS(TM)-MB2/MYDAS(TM)-MB?

The FDA product code for MYDAS(TM)-MB2/MYDAS(TM)-MB is JHX.

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Other records listing Intl. Immunoassay Laboratories, 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.

K913349STAMBI-CKK912231PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KITK903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTSK903508LABELLING CHANGES TO IMPRES-MB-XK901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBK890609IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

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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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