JMAClass I
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
21 CFR 862.1095 / Clinical Chemistry
JMA is the FDA product code for Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric), a class I device type, regulated under 21 CFR 862.1095. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JMA
- Device name
- Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- Regulation
- 21 CFR 862.1095
- 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
- 3
- Ingested recalls
- 0
Clearances, product code JMA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1993 | 1 |
Applicants with the most clearances
Product code JMA| Applicant | Clearances |
|---|---|
| Helena Laboratories, Corp. | 1 |
| Laprol Scientific, Inc. | 1 |
| Quantimetrix Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acon Biotech (Hangzhou) Co., Ltd.
- Acon Laboratories, Inc.
- Alius Scientific,LLC
- Assure Tech LLC
- Ave Science & Technology Co., Ltd
- Beckman Coulter Ireland Inc
- BTNX Inc.
- Changchun LYZ Technology Co.,LTD
- Changchun Merydi Bio-Tech Co., Ltd.
- Changchun Wancheng Bio-Electron Co., Ltd.
- Chromsystems Instruments & Chemicals GmbH
- Chungdo Pharm. Co., Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
