BIOTRACK APTT CONTROLS
FDA 510(k) clearance K890051 · decided 1989-02-23
Clearance details
- K-number
- K890051
- Device name
- BIOTRACK APTT CONTROLS
- Applicant
- Biotrack, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-06
- Decision date
- 1989-02-23
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- GIT
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| PLATELIN(R) EXCEL L (K881999) | Organon Teknika Corp. | 1988-08-17 |
| CLP 0.02 M CALCIUM CHLORIDE SOLUTION. (K880711) | Creative Laboratory Products, Inc. | 1988-03-18 |
| THROMBOSCREEN (K820450) | Pacific Hemostasis | 1982-03-26 |
Recalls involving this device
No recalls on record reference this clearance.