JQPClass I
Calculator/Data Processing Module, For Clinical Use
21 CFR 862.2100 / Clinical Chemistry
JQP is the FDA product code for Calculator/Data Processing Module, For Clinical Use, a class I device type, regulated under 21 CFR 862.2100. As of , FDA records hold 78 510(k) clearances under this code, the most recent dated , and 218 recalls.
Classification record
- Product code
- JQP
- Device name
- Calculator/Data Processing Module, For Clinical Use
- Regulation
- 21 CFR 862.2100
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 78
- Ingested recalls
- 218
Clearances, product code JQP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 5 |
| 1980 | 13 |
| 1981 | 5 |
| 1982 | 11 |
| 1983 | 7 |
| 1984 | 7 |
| 1985 | 4 |
| 1986 | 5 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code JQP| Applicant | Clearances |
|---|---|
| Miles Laboratories, Inc. | 8 |
| Instrumentation Laboratory Co. | 5 |
| Syva Co. | 5 |
| Biovation, Inc. | 4 |
| Corning Medical & Scientific | 4 |
| E.I. Dupont de Nemours & Co., Inc. | 3 |
| Union Carbide Corp. | 3 |
| American Dade | 2 |
| Beckman Instruments, Inc. | 2 |
| Ciba Corning Diagnostics Corp. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
