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FDA 510(k)

IMPRES-MB REAGENT A AND REAGENT B

K-Number: K890543 · 1989-03-13

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1989-03-13
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMPRES-MB REAGENT A AND REAGENT B 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 1989-03-13 under 510(k) number K890543. 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 IMPRES-MB REAGENT A AND REAGENT B?

IMPRES-MB REAGENT A AND REAGENT B is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K890543.

When did IMPRES-MB REAGENT A AND REAGENT B receive FDA 510(k) clearance?

IMPRES-MB REAGENT A AND REAGENT B received FDA 510(k) clearance on 1989-03-13, under 510(k) number K890543.

Who is the listed applicant for IMPRES-MB REAGENT A AND REAGENT B?

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 IMPRES-MB REAGENT A AND REAGENT B?

The FDA product code for IMPRES-MB REAGENT A AND REAGENT B 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.

K913380MYDAS(TM)-MB2/MYDAS(TM)-MBK913349STAMBI-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-MB

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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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