CALCIUM QVET
FDA 510(k) clearance K943003 · decided 1994-12-09
Clearance details
- K-number
- K943003
- Device name
- CALCIUM QVET
- Applicant
- Prisma Systems
- Decision
- Substantially Equivalent
- Date received
- 1994-06-23
- Decision date
- 1994-12-09
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- CJJ
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rome, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOTRACK ALT TEST CARTRIDGE (K895128) | Biotrack, Inc. | 1989-10-06 |
Recalls involving this device
No recalls on record reference this clearance.