GJG
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pipette, Quantitative, Hematology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6160
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1994: 1 · 2006: 18 · 2007: 11
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 |
|---|---|---|
| LIQUIPETTE (K831079) | The Kendall Company Div. of Tyco Healthcare Group | 1983-04-28 |
| PIPETTES, PLASTIC DISPOSABLE (K781891) | Hillwood Corp. | 1978-11-15 |
| DISPOSABLE CONTROLLED DROP PASTEUR PIPET (K780237) | Owens-Illinois, Inc. | 1978-03-09 |
| UNIFORM DROP SIZE PASTEUR TYPE PIPETS (K760719) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-29 |
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Every clearance here is in the API, with alerts when new ones post.