CSF TOTAL PROTEIN TEST SET #0340
FDA 510(k) clearance K780110 · decided 1978-03-03
Clearance details
- K-number
- K780110
- Device name
- CSF TOTAL PROTEIN TEST SET #0340
- Applicant
- Stanbio Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1978-01-19
- Decision date
- 1978-03-03
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JGQ
- Device class
- 2
- Regulation number
- 862.1635
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
| TOTAL PROTEIN URINE/CSF GEN.3 (K071239) | Roche Diagnostics | 2007-09-14 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.