Atlas FDA

VANCOMYCIN FLEX REAGENT CARTRIDGE

FDA 510(k) clearance K963267 · decided 1996-09-13

Clearance details

K-number
K963267
Device name
VANCOMYCIN FLEX REAGENT CARTRIDGE
Applicant
Dade Intl., Inc.
Decision
Substantially Equivalent
Date received
1996-08-20
Decision date
1996-09-13
Days to decision
24 days
Clearance type
Traditional
Product code
LEH
Device class
2
Regulation number
862.3950
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Dade Intl.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439)Siemens Healthcare Diagnostics, Inc.2023-08-08
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (K160202)Siemens Healthcare Diagnostics, Inc.2016-04-27
ONLINE TDM Vancomycin Gen.3 (K152245)Roche Diagnostics Operations (Rdo)2016-01-08
ARCHITECT IVANCOMYCIN (K123947)Biokit, S.A.2013-08-29
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 (K072036)Biokit, S.A.2008-03-19
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045)Diagnostic Products Corp.2006-12-05
ENZYME IMMUNOASSAY, VANCOMYCIN (K060586)Roche Diagnostics Corp.2006-05-11
QMS VANCOMYCIN (K050419)Seradyn, Inc.2005-04-01
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386)Ortho-Clinical Diagnostics, Inc.2005-02-07
CEDIA VANCOMYCIN ASSAY (K032811)Microgenics Corp.2003-11-24
EMIT 2000 VANCOMYCIN ASSAY (K020692)Dade Behring, Inc.2002-05-10
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076)Beckman Coulter, Inc.2001-12-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS (P870049/S032)Dade Intl., Inc.2001-11-30
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S031)Dade Intl., Inc.2001-11-09
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S030)Dade Intl., Inc.2000-06-05
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S029)Dade Intl., Inc.1999-06-24
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S028)Dade Intl., Inc.1999-01-25
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S027)Dade Intl., Inc.1998-06-30
MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS (P870049/S025)Dade Intl., Inc.1996-05-03
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S024)Dade Intl., Inc.1996-03-12