FDA Product Code
FDA Product Code DGR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5700
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961544 | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | Consolidated Technologies, Inc. | 1996-09-24 | Traditional | PDF ↗ |
| K902220 | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | Boehringer Mannheim Corp. | 1990-09-05 | Traditional | PDF ↗ |
| K865014 | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | Bio-Rad | 1987-01-09 | Traditional | PDF ↗ |
| K790298 | RADIOASSAY, CONTROL SERUM I, II, III | Kallestad Laboratories, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K781355 | ICS NORMAL CONTROL SERUM | Beckman Instruments, Inc. | 1978-08-31 | Traditional | PDF ↗ |
Product code DGR · Class I · Immunology. Data: openFDA.