Atlas FDA

CALCIUM

FDA 510(k) clearance K062855 · decided 2006-11-22

Clearance details

K-number
K062855
Device name
CALCIUM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2006-09-25
Decision date
2006-11-22
Days to decision
58 days
Clearance type
Traditional
Product code
CJY
Device class
2
Regulation number
862.1145
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, 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
Calcium2 (K244042)Abbott Ireland2025-02-10
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396)HORIBA ABX SAS2019-07-26
Randox Calcium (Ca) (K182042)Randox Laboratories, Ltd.2018-10-23
ELITech Clinical Systems CALCIUM ARSENAZO (K151113)Elitechgroup2015-07-22
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (K123171)HORIBA ABX SAS2013-07-03
EON CALCIUM REGENT (K120626)Vital Diagnostics (Manufacturing) Ptyltd2012-08-22
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (K083386)Siemens Healthcare Diagnostics2009-04-02
S-TEST CA (K072356)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
CALCIUM, SCAL, NORTROL, ABTROL (K073355)Thermofisher Scientific OY2008-02-28
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (K072443)Ortho-Clinical Diagnostics, Inc.2007-09-24
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) (K072440)Ortho-Clinical Diagnostics, Inc.2007-09-20
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (K061575)Olympus America, Inc.2006-10-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30