FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
K Number: K850907
·
Decision Jun 25, 1985
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
12
Review Days
112
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Basic Information
- Device Name
- CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
- K Number
- K850907
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cala Diagnostics
- Date Received
- March 5, 1985
- Decision Date
- June 25, 1985
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Cala Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | Oct 31, 1994 | Substantially Equivalent |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | Oct 31, 1994 | Substantially Equivalent |
| K944243 | CARDIOCHEX | Oct 27, 1994 | Substantially Equivalent |
| K930874 | LD-1 CONTROL-LEVEL 1 & 2 | Apr 22, 1993 | Substantially Equivalent |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | Apr 13, 1993 | Substantially Equivalent |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | Apr 13, 1993 | Substantially Equivalent |
| K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 | Dec 28, 1992 | Substantially Equivalent |
| K915503 | FIBRINOGEN FDP CONTROL | Jan 30, 1992 | Substantially Equivalent |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Aug 12, 1991 | Substantially Equivalent |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Jul 26, 1991 | Substantially Equivalent |