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FDA 510(k)

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K873171 · 1987-09-29

ApplicantAmerican Dade
Decision Date1987-09-29
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-09-29 under 510(k) number K873171. 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 STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-09-29. The listed applicant is American Dade. The 510(k) number is K873171.

When did STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1987-09-29, under 510(k) number K873171.

Who is the listed applicant for STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY is JHX.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & IIIK871972STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY

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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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