Atlas FDA

VISION (TM) CALCIUM

FDA 510(k) clearance K863670 · decided 1986-11-13

Clearance details

K-number
K863670
Device name
VISION (TM) CALCIUM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1986-09-18
Decision date
1986-11-13
Days to decision
56 days
Clearance type
Traditional
Product code
CIC
Device class
2
Regulation number
862.1145
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (K130870)Hitachi Chemical Diagnostics, Inc.2013-05-02
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (K083339)Siemens Healthcare Diagnostics, Inc.2009-03-09
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H (K070249)Horiba Abx2007-04-26
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (K053401)Arkray, Inc.2006-03-24
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (K050077)Arkray, Inc.2005-02-15
RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009)Hemagen Diagnostics, Inc.2004-06-25
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (K023105)Elan Diagnostics2003-03-13
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (K013652)Wiener Laboratories Saic2001-12-21
RANDOX CALCIUM (K000375)Randox Laboratories, Ltd.2000-04-05
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 (K991111)A.P. Total Care, Inc.1999-05-25
CALCIUM REAGENT (K971907)Carolina Liquid Chemistries Corp.1997-06-24
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292)Roche Diagnostic Systems, Inc.1996-10-31

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