DGR
5 FDA 510(k) clearances · Product code
51 daysmedian time to decision
155 days90th percentile
5clearances measured
FDA profile
- Official device name
- Whole Human Serum, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5700
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 2003: 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 |
|---|---|---|
| QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (K961544) | Consolidated Technologies, Inc. | 1996-09-24 |
| PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (K902220) | Boehringer Mannheim Corp. | 1990-09-05 |
| LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014) | Bio-Rad | 1987-01-09 |
| RADIOASSAY, CONTROL SERUM I, II, III (K790298) | Kallestad Laboratories, Inc. | 1979-04-04 |
| ICS NORMAL CONTROL SERUM (K781355) | Beckman Instruments, Inc. | 1978-08-31 |
Track DGR automatically
Every clearance here is in the API, with alerts when new ones post.