JJCClass I
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
21 CFR 862.2150 / Clinical Chemistry
JJC is the FDA product code for Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, a class I device type, regulated under 21 CFR 862.2150. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- JJC
- Device name
- Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Regulation
- 21 CFR 862.2150
- 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
- 32
- Ingested recalls
- 1
Clearances, product code JJC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 5 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 2 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1994 | 1 |
| 1995 | 2 |
Applicants with the most clearances
Product code JJC| Applicant | Clearances |
|---|---|
| Technicon Instruments Corp. | 12 |
| Gilford Instrument Laboratories, Inc. | 2 |
| Alpkem Corp. | 1 |
| American Research Products Co. | 1 |
| Avl Scientific Corp. | 1 |
| Baxter Healthcare Corporation | 1 |
| Boehringer Mannheim Corp. | 1 |
| Instrumentation Laboratory Co. | 1 |
| Lachat Chemicals, Inc. | 1 |
| Methodist Hospital of Memphis | 1 |
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.
