JGPClass II
Lowry (Colorimetric), Total Protein
21 CFR 862.1635 / Clinical Chemistry
JGP is the FDA product code for Lowry (Colorimetric), Total Protein, a class II device type, regulated under 21 CFR 862.1635. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- JGP
- Device name
- Lowry (Colorimetric), Total Protein
- Regulation
- 21 CFR 862.1635
- Device class
- Class II
- 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
- 5
- Ingested recalls
- 2
Clearances, product code JGP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1982 | 1 |
| 1986 | 1 |
| 1997 | 1 |
| 2007 | 1 |
Applicants with the most clearances
Product code JGP| Applicant | Clearances |
|---|---|
| Biovation, Inc. | 1 |
| J. D. Assoc. | 1 |
| Johnson & Johnson Clinical Diagnostics, Inc. | 1 |
| Panmed, Inc. | 1 |
| Horiba Instruments Incorporated | 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.
