Atlas FDA

VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III

FDA 510(k) clearance K042494 · decided 2004-10-19

Clearance details

K-number
K042494
Device name
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
Applicant
Ortho-Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2004-09-14
Decision date
2004-10-19
Days to decision
35 days
Clearance type
Traditional
Product code
CZW
Device class
2
Regulation number
866.5240
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
SPAPLUS (K100179)The Binding Site Group , Ltd.2010-08-13
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IBL C3D-CIC EIA TEST (K032796)Ibl GmbH2004-01-13
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI (K032035)Beckman Coulter, Inc.2003-08-07
TINA-QUANT COMPLEMENT C3C TEST SYSTEM (K012361)Roche Diagnostics Corp.2001-11-29
WAKO AUTOKIT C3 (K010326)Wako Chemicals USA, Inc.2001-06-25
RANDOX COMPLEMENT C3 (K000469)Randox Laboratories, Ltd.2000-03-27
DIMENSION C3 FLEX REAGENT CARTRIDGE (K994296)Dade Behring, Inc.2000-03-01
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K-ASSAY C3 (K993437)Kamiya Biomedical Co.1999-11-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02