GIT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reagent & Control, Partial Thromboplastin Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 6 · 2004: 2 · 2005: 11 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIOTRACK APTT CONTROLS (K890051) | Biotrack, Inc. | 1989-02-23 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.