510(k) K043386
- Device
- VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- 510(k) number
- K043386
- Product code
- LEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-07
- Date received
- 2004-12-09
- Regulation
- 862.3950
- Classification name
- Radioimmunoassay, Vancomycin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAREY A MAYO
- Address
- 100 Indigo Creek Dr. Rochester NY US 14626 14626
FDA Registration Numbers#
- 2432235
- 3012963943
- 1319681
- 2050010
- 3002642396
- 3003795116
- 3010939897
- 2250051
- 8020888
- 3002809144
- 3003561301
- 3005755244
- 9610529
- 1319808
- 3004493545
- 9610746
- 9610126
- 1317202
- 3010825766
- 2517506
- 3033967997
- 3002806944
- 3000308930
- 1219913
- 3005333358
- 2050012
- 3006198300
Source Documents#
Other 510(k) Records For Product Code LEH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023-08-08 |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | 2016-04-27 |
| K152245 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics Operations (Rdo) | 2016-01-08 |
| K123947 | ARCHITECT IVANCOMYCIN | Biokit, S.A. | 2013-08-29 |
| K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 | Biokit, S.A. | 2008-03-19 |
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Diagnostic Products Corp. | 2006-12-05 |
| K060586 | ENZYME IMMUNOASSAY, VANCOMYCIN | Roche Diagnostics Corp. | 2006-05-11 |
| K050419 | QMS VANCOMYCIN | Seradyn, Inc. | 2005-04-01 |
| K032811 | CEDIA VANCOMYCIN ASSAY | Microgenics Corp. | 2003-11-24 |
| K020692 | EMIT 2000 VANCOMYCIN ASSAY | Dade Behring, Inc. | 2002-05-10 |
| K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR | Beckman Coulter, Inc. | 2001-12-12 |
| K983280 | VANCOMYCIN EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-06 |
| K964587 | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1997-01-13 |
| K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 |
| K955851 | AXSYM VANCOMYCIN II | Abbott Laboratories | 1996-05-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary