GJE
7 FDA 510(k) clearances · Product code
35 daysmedian time to decision
529 days90th percentile
7clearances measured
FDA profile
- Official device name
- Tray, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2005: 14 · 2006: 25 · 2007: 7 · 2008: 3 · 2009: 3 · 2010: 3
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 |
|---|---|---|
| CUSTOMED BLOOD EXTRACTION KIT (K962596) | Customed, Inc. | 1996-09-27 |
| JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (K925468) | J.J. Skinner, Inc. | 1994-04-11 |
| AUTO ISO-FILTER COLLECTION TUBE CAP (K780303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-30 |
| RTERIAL BLOOD SAMPLING KIT (K771489) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-22 |
| ICROTAINEO BRAND TUBE (K771370) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-03 |
| SODIUM CITRATE (K761177) | Bio/Data Corp. | 1977-01-10 |
| TRAY, BLOOD SAMPLING (PULSATOR II) (K760086) | Concord Laboratories, Inc. | 1976-07-16 |
Track GJE automatically
Every clearance here is in the API, with alerts when new ones post.