TOTAL PROTEIN URINE/CSF GEN.3
FDA 510(k) clearance K071239 · decided 2007-09-14
Clearance details
- K-number
- K071239
- Device name
- TOTAL PROTEIN URINE/CSF GEN.3
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-05-03
- Decision date
- 2007-09-14
- Days to decision
- 134 days
- Clearance type
- Special
- Product code
- JGQ
- Device class
- 2
- Regulation number
- 862.1635
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (K131051) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638) | Roche Diagnostics Corp. | 2007-10-19 |
| UPRO (K981295) | Abbott Laboratories | 1998-10-01 |
| UPRO (K981682) | Abbott Laboratories | 1998-09-21 |
| TRACE MICROPROTEIN REAGENT (K925794) | Trace America, Inc. | 1993-03-29 |
| URINARY/CSF PROTEIN (K913615) | Boehringer Mannheim Corp. | 1991-09-13 |
| PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (K903914) | Baxter Healthcare Corp | 1990-10-03 |
| EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (K901083) | Em Diagnostic Systems, Inc. | 1990-04-16 |
| CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (K863478) | Em Diagnostic Systems, Inc. | 1986-10-29 |
| SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (K842134) | Somas Medical Industries, Inc. | 1984-07-06 |
| ACA URINARY PROTEIN ANALYTICAL TEST PACK (K822231) | E.I. Dupont DE Nemours & Co., Inc. | 1982-09-30 |
| CSF TOTAL PROTEIN TEST SET #0340 (K780110) | Stanbio Laboratory | 1978-03-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |