BIOTRACK ALT TEST CARTRIDGE
FDA 510(k) clearance K895128 · decided 1989-10-06
Clearance details
- K-number
- K895128
- Device name
- BIOTRACK ALT TEST CARTRIDGE
- Applicant
- Biotrack, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-17
- Decision date
- 1989-10-06
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- CJJ
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mountain View, CA, 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 |
|---|---|---|
| CALCIUM QVET (K943003) | Prisma Systems | 1994-12-09 |
Recalls involving this device
No recalls on record reference this clearance.