Atlas FDA

VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

FDA 510(k) clearance K001885 · decided 2000-07-20

Clearance details

K-number
K001885
Device name
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2000-06-21
Decision date
2000-07-20
Days to decision
29 days
Clearance type
Special
Product code
CDN
Device class
2
Regulation number
862.1770
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
VITROS XT Chemistry Products UREA-CREA Slides (K190326)Ortho-Clinical Diagnostics, Inc.2019-03-14
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (K132462)Hitachi Chemical Diagnostics, Inc.2013-10-28
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ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (K113389)Alfa Wassermann Diagnostic Technologies, Inc.2012-08-10
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD (K103615)Alfa Wassermann Diagnostic Technologies, Inc.2011-09-08
CHOLESTECH BUN/CREATININE TEST SYSTEM (K972012)Cholestech Corp.1997-07-24
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (K961196)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-15
BUN QVET (K943042)Prisma Systems1994-12-29
KING DIAGNOSTICS UREA NITROGEN REAGENT (K922969)King Diagnostics, Inc.1992-10-13
QUICKSTART UREA NITROGEN (K914903)Em Diagnostic Systems, Inc.1991-12-31
UREA NITROGEN (ENZYMATIC) DETERMINATION (K822154)The Dow Chemical Co.1982-08-05
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Recalls involving this device

RecordFirmDate
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. recall (Z-1837-2025)Mckesson Medical-Surgical Inc. Corporate Office2025-05-27
VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 81022 recall (Z-0301-2014)Ortho-Clinical Diagnostics2013-11-15

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19