JIQClass I
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
21 CFR 862.1645 / Clinical Chemistry
JIQ is the FDA product code for Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.), a class I device type, regulated under 21 CFR 862.1645. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- JIQ
- Device name
- Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- Regulation
- 21 CFR 862.1645
- 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
- 13
- Ingested recalls
- 1
Clearances, product code JIQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 2 |
| 1999 | 1 |
| 2003 | 1 |
| 2014 | 1 |
Applicants with the most clearances
Product code JIQ| Applicant | Clearances |
|---|---|
| Beckman Instruments, Inc. | 2 |
| FUJIFILM Healthcare Americas Corporation | 2 |
| Ausam Biotecthnologies, Inc. | 1 |
| Diagnostic Specialties | 1 |
| Dupont Medical Products | 1 |
| E K Ind., Inc. | 1 |
| Osborn Group, Inc. | 1 |
| Reagents Applications, Inc. | 1 |
| Roche Diagnostics Operations (Rdo) | 1 |
| Sclavo, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Ireland Diagnostics Division
- Abbott Medical
- Biomerica de Mexico, S.A. de C.V.
- Changchun LYZ Technology Co.,LTD
- Elhoda Trade and Supplies
- Fisher Diagnostics
- FUJIFILM Healthcare Americas Corporation
- FUJIFILM Healthcare Manufacturing Corporation MIE Office
- FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)
- Horiba Abx SAS
- Infrared Laboratory Systems dba SYNERMED
- Jilin Test Bio-Electron 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.
