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MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

FDA 510(k) clearance K000566 · decided 2000-03-09

Clearance details

K-number
K000566
Device name
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2000-02-22
Decision date
2000-03-09
Days to decision
16 days
Clearance type
Special
Product code
LTJ
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
Atellica IM Total PSA II (tPSAII) (K251630)Siemens Healthcare Diagnostics, Inc.2026-01-05
FREND PSA PLUS (reagent cartridge) (K162378)Nanoentek USA, Inc.2017-05-17
FREND PSA PLUS (REAGENT CARTRIDGE) (K124056)Nanoentek, Inc.2013-05-29
TPSA FLEX REAGENT CARTRIDGE (K031343)Dade Behring, Inc.2003-05-15
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177)Bayer Diagnostics Corp.2002-12-17
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022288)Bayer Corp.2002-12-17
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550)bioMerieux, Inc.2001-04-24
DIMENSION PSA FLEX REAGENT CARTRIDGE (K003963)Dade Behring, Inc.2001-02-28
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376)Bayer Corp.2000-10-26
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (K003094)Qualigen, Inc.2000-10-25
TOTAL PSA MICROTITER ELISA (K002121)Oncogene Science, Inc.2000-08-30
COMPLEXED PSA MICROTITER ELISA (K002313)Oncogene Science, Inc.2000-08-30

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