GKJ
6 FDA 510(k) clearances · Product code
31 daysmedian time to decision
87 days90th percentile
6clearances measured
FDA profile
- Official device name
- Spinner, Slide, Automated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.5850
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1997: 1 · 2010: 3 · 2011: 23 · 2012: 66
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 |
|---|---|---|
| MICRO-MAT SYSTEM (K854962) | Ulster Scientific, Inc. | 1985-12-23 |
| MICRO-MAT SYSTEM (K854121) | Prevo Micro-Mat System | 1985-10-31 |
| E-Z PREP (K831558) | Coulter Electronics, Inc. | 1983-06-16 |
| HEMASPINNER (K811534) | Geometric Data, Div. Smithkline Corp. | 1981-08-18 |
| AUTOMATED SLIDE SPINNER (K771898) | Dynatech Cryomedical Co. | 1977-10-18 |
| BLOOD-SMEARING INSTRUMENT (MINIPREP TM) (K760007) | Geometric Data, Div. Smithkline Corp. | 1976-09-03 |
Track GKJ automatically
Every clearance here is in the API, with alerts when new ones post.