510(k) K131051
- Device
- HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
- Applicant
- HITACHI CHEMICAL DIAGNOSTICS, INC.
- 510(k) number
- K131051
- Product code
- JGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-06-07
- Date received
- 2013-04-15
- Regulation
- 862.1635
- Classification name
- Turbidimetric, Total Protein
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIKA AMMIRATI
- Address
- 575 Shirlynn Ct. Los Angeles CA US 94022 94022
FDA Registration Numbers#
- 9610529
- 9610126
- 3016438761
- 3005333358
- 3006198300
- 3003795116
- 3003741796
- 1181121
Source Documents#
Other 510(k) Records For Product Code JGQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072638 | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | Roche Diagnostics Corp. | 2007-10-19 |
| K071239 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics | 2007-09-14 |
| K981295 | UPRO | Abbott Laboratories | 1998-10-01 |
| K981682 | UPRO | Abbott Laboratories | 1998-09-21 |
| K925794 | TRACE MICROPROTEIN REAGENT | Trace America, Inc. | 1993-03-29 |
| K913615 | URINARY/CSF PROTEIN | Boehringer Mannheim Corp. | 1991-09-13 |
| K903914 | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | Baxter Healthcare Corp | 1990-10-03 |
| K901083 | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | Em Diagnostic Systems, Inc. | 1990-04-16 |
| K863478 | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | Em Diagnostic Systems, Inc. | 1986-10-29 |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Somas Medical Industries, Inc. | 1984-07-06 |
| K822231 | ACA URINARY PROTEIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1982-09-30 |
| K780110 | CSF TOTAL PROTEIN TEST SET #0340 | Stanbio Laboratory | 1978-03-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary