FDA Product Code
FDA Product Code JGQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1635
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | Traditional | PDF ↗ |
| K072638 | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | Roche Diagnostics Corp. | 2007-10-19 | Special | PDF ↗ |
| K071239 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics | 2007-09-14 | Special | PDF ↗ |
| K981295 | UPRO | Abbott Laboratories | 1998-10-01 | Traditional | PDF ↗ |
| K981682 | UPRO | Abbott Laboratories | 1998-09-21 | Traditional | PDF ↗ |
| K925794 | TRACE MICROPROTEIN REAGENT | Trace America, Inc. | 1993-03-29 | Traditional | PDF ↗ |
| K913615 | URINARY/CSF PROTEIN | Boehringer Mannheim Corp. | 1991-09-13 | Traditional | PDF ↗ |
| K903914 | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | Baxter Healthcare Corp | 1990-10-03 | Traditional | PDF ↗ |
| K901083 | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | Em Diagnostic Systems, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K863478 | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | Em Diagnostic Systems, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Somas Medical Industries, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K822231 | ACA URINARY PROTEIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K780110 | CSF TOTAL PROTEIN TEST SET #0340 | Stanbio Laboratory | 1978-03-03 | Traditional | PDF ↗ |
Product code JGQ · Class II · Clinical Chemistry. Data: openFDA.