FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA-QUANT CK-MB TEST KIT
K Number: K792504
·
Decision Jan 16, 1980
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
92
Review Days
43
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
- RIA-QUANT CK-MB TEST KIT
- K Number
- K792504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Mallinckrodt Critical Care
- Date Received
- December 4, 1979
- Decision Date
- January 16, 1980
- 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 Mallinckrodt Critical Care
| K Number | Device Name | ||
|---|---|---|---|
| K880343 | BURNEY GALLBLADDER CATHETER KIT | May 1, 1989 | Substantially Equivalent |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Feb 2, 1988 | Substantially Equivalent |
| K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | Jan 29, 1988 | Substantially Equivalent |
| K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR | Jan 6, 1988 | Substantially Equivalent |
| K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR | Nov 6, 1987 | Substantially Equivalent |
| K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | Nov 6, 1987 | Substantially Equivalent |
| K873833 | THERMOCOUPLE ADAPTER | Nov 3, 1987 | Substantially Equivalent |
| K873004 | GUIDING CATHETER | Sep 15, 1987 | Substantially Equivalent |
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | Apr 21, 1987 | Substantially Equivalent |
| K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | Aug 1, 1986 | Substantially Equivalent |