Panels › Clinical Toxicology › Product code LEH · Class 2
Radioimmunoassay, Vancomycin
Regulation 862.3950
0510(k)s in 12 months (31 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in LEH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2023 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) Siemens Healthcare Diagnostics, Inc. | LEH |
| Apr 27, 2016 | K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) Siemens Healthcare Diagnostics, Inc. | LEH |
| Jan 8, 2016 | K152245 | ONLINE TDM Vancomycin Gen.3 Roche Diagnostics Operations (Rdo) | LEH |
| Aug 29, 2013 | K123947 | ARCHITECT IVANCOMYCIN Biokit, S.A., ES | LEH |
| Mar 19, 2008 | K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 Biokit, S.A., ES | LEH |
| Dec 5, 2006 | K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN Diagnostic Products Corp. | LEH |
| May 11, 2006 | K060586 | ENZYME IMMUNOASSAY, VANCOMYCIN Roche Diagnostics Corp. | LEH |
| Apr 1, 2005 | K050419 | QMS VANCOMYCIN Seradyn, Inc. | LEH |
| Feb 7, 2005 | K043386 | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. | LEH |
| Nov 24, 2003 | K032811 | CEDIA VANCOMYCIN ASSAY Microgenics Corp. | LEH |
| May 10, 2002 | K020692 | EMIT 2000 VANCOMYCIN ASSAY Dade Behring, Inc. | LEH |
| Dec 12, 2001 | K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR Beckman Coulter, Inc. | LEH |
| Nov 6, 1998 | K983280 | VANCOMYCIN EIA ASSAY Diagnostic Reagents, Inc. | LEH |
| Jan 13, 1997 | K964587 | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. | LEH |
| Sep 13, 1996 | K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LEH |
| May 9, 1996 | K955851 | AXSYM VANCOMYCIN II Abbott Laboratories | LEH |
| Feb 16, 1996 | K955716 | VANCOMYCIN FPIA REAGENT SET Sigma Diagnostics, Inc. | LEH |
| Sep 12, 1995 | K953528 | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN Roche Diagnostic Systems, Inc. | LEH |
| Jun 19, 1995 | K951059 | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | LEH |
| Mar 10, 1995 | K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD The DU Pont Co. | LEH |
| Jun 21, 1994 | K940595 | AXSYM VANCOMYCIN Abbott Laboratories | LEH |
| Dec 11, 1992 | K924957 | OPUS(R) VANCOMYCIN Pb Diagnostic Systems, Inc. | LEH |
| May 2, 1990 | K901759 | COBAS-FP REAGENTS FOR VANCOMYCIN Roche Diagnostic Systems, Inc. | LEH |
| Apr 19, 1990 | K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LEH |
| May 22, 1989 | K892900 | ACA VANCOMYCIN (VANC) METHOD E.I. Dupont DE Nemours & Co., Inc. | LEH |
| Apr 19, 1988 | K881040 | EMIT VANCOMYCIN ASSAY Syva Co. | LEH |
| Jan 21, 1988 | K874438 | STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp | LEH |
| Aug 17, 1987 | K872579 | INNOFLUOR VANCOMYCIN REAGENT SET Innotron of Oregon, Inc. | LEH |
| Aug 16, 1982 | K822308 | VANCOMYCIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LEH |
| May 13, 1982 | K821136 | TDX TM STREPTOMYCIN Abbott Laboratories | LEH |
| Dec 8, 1981 | K813218 | TDX VANCOMYCIN Abbott Laboratories | LEH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.