DGR — Whole Human Serum, Antigen, Antiserum, Control Class I
FDA Device Classification
Classification Details
- Product Code
- DGR
- Device Class
- Class I
- Regulation Number
- 866.5700
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K961544 | consolidated technologies | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | September 24, 1996 |
| K902220 | boehringer mannheim | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | September 5, 1990 |
| K865014 | bio-rad | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | January 9, 1987 |
| K790298 | kallestad laboratories | RADIOASSAY, CONTROL SERUM I, II, III | April 4, 1979 |
| K781355 | beckman instruments | ICS NORMAL CONTROL SERUM | August 31, 1978 |