Atlas FDA

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

FDA 510(k) clearance K083173 · decided 2008-12-22

Clearance details

K-number
K083173
Device name
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
Applicant
Ortho-Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2008-10-27
Decision date
2008-12-22
Days to decision
56 days
Clearance type
Special
Product code
JLW
Device class
2
Regulation number
862.1690
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: recall (Z-1007-2025)Ortho-Clinical Diagnostics, INc.2025-01-21
VITROS 3600 Immunodiagnostic System (New and Refurbished) recall (Z-1220-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbishe recall (Z-1224-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbishe recall (Z-1229-2024)Ortho-Clinical Diagnostics, Inc.2024-03-01
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802 recall (Z-0543-2024)Ortho-Clinical Diagnostics, Inc.2023-12-13
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product recall (Z-0008-2024)Ortho-Clinical Diagnostics, Inc.2023-10-02
VITROS Immunodiagnostic Products TSH Reagent Pack recall (Z-1322-2018)Clinical Diagnostic Systems2018-04-10
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 1075 recall (Z-0640-2016)Ortho-Clinical Diagnostics2016-01-13
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagno recall (Z-0967-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, recall (Z-0968-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. recall (Z-0969-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantit recall (Z-2139-2014)Ortho-Clinical Diagnostics2014-08-01
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the i recall (Z-1650-2013)Ortho-Clinical Diagnostics2013-07-02
VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in recall (Z-1468-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 - recall (Z-1072-2012)Ortho-Clinical Diagnostics2012-02-21
VITROS 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS 5600 --- NOTE recall (Z-1073-2012)Ortho-Clinical Diagnostics2012-02-21

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