JGQ — Turbidimetric, Total Protein Class II
FDA product code JGQ covers "Turbidimetric, Total Protein", a Class II medical device regulated under 21 CFR 862.1635. Submissions are reviewed by the Clinical Chemistry panel. At least 13 recent 510(k) clearances have been granted under this product code.
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 |