FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIA-PACK CK-MB
K Number: K913298
·
Decision Sep 27, 1991
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
11
Review Days
64
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
- AIA-PACK CK-MB
- K Number
- K913298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Corp.
- Date Received
- July 25, 1991
- Decision Date
- September 27, 1991
- 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 Tosoh Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023240 | ST AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K023239 | AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Jul 21, 1992 | Substantially Equivalent |
| K913663 | AIA-PACK T-U | Sep 30, 1991 | Substantially Equivalent |
| K913493 | AIA-PACK FT4 | Sep 10, 1991 | Substantially Equivalent |
| K903628 | AIA-PACK IRI | Sep 7, 1990 | Substantially Equivalent |
| K901965 | MPR-4A - MICRO-PLATE READER | May 10, 1990 | Substantially Equivalent |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | May 2, 1990 | Substantially Equivalent |
| K897001 | TOSOH AIA-PACK T3 | Mar 9, 1990 | Substantially Equivalent |
| K896982 | AIA-PACK T4 | Mar 9, 1990 | Substantially Equivalent |