510(k) K891581
- Device
- Cobas-fp Reagent For Valproic Acid & Calibrators
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K891581
- Product code
- LEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-15
- Date received
- 1989-03-20
- Regulation
- 862.3645
- Classification name
- Enzyme Immunoassay, Valproic Acid
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALEX WESOLOWSKI
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
FDA Registration Numbers#
- 3006198300
- 3003795116
- 2050012
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 1319808
- 3010939897
- 3002809144
- 2517506
- 1036362
- 3004493545
- 3002642396
- 2050010
- 3010825766
- 3003871639
- 9610126
- 1319681
- 3000308930
- 3002806944
- 3003561301
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LEG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090358 | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 | Abbott Laboratories, Inc. | 2009-08-06 |
| K060690 | ONLINE VALPROIC ACID | Roche Diagnostics Corp. | 2006-08-08 |
| K042807 | ADVIA IMS VALPROIC ACID METHOD | Bayer Healthcare, LLC | 2005-02-08 |
| K042476 | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS | Ortho-Clinical Diagnostics, Inc. | 2004-12-01 |
| K032049 | ROCHE ONLINE TDM VALPROIC ACID | Roche Diagnostics Corp. | 2003-08-22 |
| K031870 | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT | Beckman Coulter, Inc. | 2003-07-15 |
| K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | Seradyn | 2003-04-28 |
| K011649 | RANDOX VALPROIC ACID | Randox Laboratories, Ltd. | 2002-01-15 |
| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Syva Co. | 2001-07-02 |
| K002551 | EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL | Dade Behring, Inc. | 2000-10-11 |
| K000005 | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 | Diagnostic Products Corp. | 2000-03-03 |
| K982880 | DIMENSION(R) VALPROIC (VALP) ACID METHOD | Dade Behring, Inc. | 1998-08-25 |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| K972132 | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS | Sigma Diagnostics, Inc. | 1997-07-30 |
| K964442 | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-12-18 |