FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS CREATINE KINASE MB ASSAY 30-421
K Number: K962549
·
Decision Aug 30, 1996
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
49
Review Days
63
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
- VIDAS CREATINE KINASE MB ASSAY 30-421
- K Number
- K962549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- June 28, 1996
- Decision Date
- August 30, 1996
- 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 Biomerieux Vitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Mar 10, 1998 | Substantially Equivalent |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Oct 3, 1997 | Substantially Equivalent |
| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 1997 | Substantially Equivalent |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Apr 8, 1997 | Substantially Equivalent |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |
| K942049 | BIOMERIEUX HEMOLAB COFAC II | May 19, 1995 | Substantially Equivalent |