Atlas FDA

VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905

FDA 510(k) clearance K082099 · decided 2008-08-21

Clearance details

K-number
K082099
Device name
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-07-25
Decision date
2008-08-21
Days to decision
27 days
Clearance type
Special
Product code
CGZ
Device class
2
Regulation number
862.1170
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (K182072)Ortho-Clinical Diagnostics, Inc.2018-10-30
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ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER (K070531)Thermo Fisher Scientific2007-09-04
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (K060108)Roche Diagnostics Corp.2006-02-16
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (K052027)Osmetech, Inc.2005-09-29
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (K020148)Phoenix Diagnostics, Inc.2002-02-04
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (K013451)Phoenix Diagnostics, Inc.2001-12-18
DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664)Wallac OY2001-02-14
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 (K003668)Wallac OY2001-02-12
DELFIA NEONATAL IRT KIT (K993697)Wallac OY2000-06-09

Recalls involving this device

No recalls on record reference this clearance.

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