Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K972782 · 1997-08-15

ApplicantDade Intl., Inc.
Decision Date1997-08-15
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K972782. 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 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY?

DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Dade Intl., Inc.. The 510(k) number is K972782.

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

DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1997-08-15, under 510(k) number K972782.

Who is the listed applicant for DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY is JHX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972287DADE TRU-LIQUID BILIRUBIN CONTROL

View all 30 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.

↑