BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
FDA 510(k) clearance K860719 · decided 1986-05-23
Clearance details
- K-number
- K860719
- Device name
- BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
- Applicant
- Biotrack, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-26
- Decision date
- 1986-05-23
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CoaguChek Plus meter; catalog # 475729 and 12816001. recall (Z-0814-03) | Roche Diagnostics Corp. | 2003-05-14 |