JGQ — Turbidimetric, Total Protein Class II
FDA Device Classification
Classification Details
- Product Code
- JGQ
- Device Class
- Class II
- Regulation Number
- 862.1635
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K131051 | hitachi chemical diagnostics | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | June 7, 2013 |
| K072638 | roche diagnostics | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | October 19, 2007 |
| K071239 | roche diagnostics | TOTAL PROTEIN URINE/CSF GEN.3 | September 14, 2007 |
| K981295 | abbott laboratories | UPRO | October 1, 1998 |
| K981682 | abbott laboratories | UPRO | September 21, 1998 |
| K925794 | trace america | TRACE MICROPROTEIN REAGENT | March 29, 1993 |
| K913615 | boehringer mannheim | URINARY/CSF PROTEIN | September 13, 1991 |
| K903914 | baxter healthcare | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | October 3, 1990 |
| K901083 | em diagnostic systems | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | April 16, 1990 |
| K863478 | em diagnostic systems | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | October 29, 1986 |
| K842134 | somas medical industries | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | July 6, 1984 |
| K822231 | e.i. dupont de nemours and co | ACA URINARY PROTEIN ANALYTICAL TEST PACK | September 30, 1982 |
| K780110 | stanbio laboratory | CSF TOTAL PROTEIN TEST SET #0340 | March 3, 1978 |