Atlas FDA

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK

FDA 510(k) clearance K983690 · decided 1999-02-02

Clearance details

K-number
K983690
Device name
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1998-10-21
Decision date
1999-02-02
Days to decision
104 days
Clearance type
Traditional
Product code
MOI
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
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
Access BR Monitor (K240403)Beckman Coulter, Inc.2024-05-09
IMMULITE® 2000 BR-MA (K233946)Siemens Healthcare Diagnostics Products, Ltd.2024-03-13
Lumipulse G CA15-3 (K192524)Fujirebio Diagnostics,Inc.2020-09-04
ADVIA Centaur BR (K193489)Siemens Healthcare Diagnostics, Inc.2020-02-13
ADVIA Centaur CA 15-3 assay (K192777)Siemens Healthcare Diagnostics, Inc.2019-11-22
Elecsys CA 15-3 II (K181492)Roche Diagnostics2018-06-22
Elecsys CA 15-3 II (K171605)Roche Diagnostics2018-02-20
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344)Siemens Healthcare Diagnostics2011-04-18
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612)Beckman Coulter, Inc.2007-10-26
ARCHITECT CA 15-3 ASSAY (K042732)Fujirebio Diagnostics,Inc.2004-12-22
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036)Beckman Coulter, Inc.2004-02-03
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178)Bayer Diagnostics Corp.2002-11-12

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