FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K Number: K972782
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
30
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- K Number
- K972782
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Intl., Inc.
- Date Received
- July 25, 1997
- Decision Date
- August 15, 1997
- Product Code
- JHX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JHX | Fluorometric Method, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHX), ordered by most recent decision date.
Access CK-MB
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS Immunodiagnostic Products CK-MB Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PATHFAST CK-MB-II, PATHFAST MYO-II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Dade Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974343 | DADE INNOVIN | Jul 22, 1998 | Substantially Equivalent |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | Nov 17, 1997 | Substantially Equivalent |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Nov 6, 1997 | Substantially Equivalent |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | Oct 20, 1997 | Substantially Equivalent |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Sep 8, 1997 | Substantially Equivalent |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | Jul 7, 1997 | Substantially Equivalent |
| K964660 | PARAMAX CHOLESTEROL REAGENT | Jun 4, 1997 | Substantially Equivalent |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | May 2, 1997 | Substantially Equivalent |
| K964715 | PARAMAX SALICYLATE REAGENT | Apr 25, 1997 | Substantially Equivalent |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | Apr 14, 1997 | Substantially Equivalent |