Atlas FDA

C3

FDA 510(k) clearance K983441 · decided 1998-11-04

Clearance details

K-number
K983441
Device name
C3
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-09-30
Decision date
1998-11-04
Days to decision
35 days
Clearance type
Traditional
Product code
CZW
Device class
2
Regulation number
866.5240
Medical specialty
Immunology
Advisory committee
Immunology
Location
Irving, TX, 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
SPAPLUS (K100179)The Binding Site Group , Ltd.2010-08-13
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (K063150)Thermo Electron OY2007-03-19
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH (K061852)Dade Behring, Inc.2006-09-22
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (K050665)Dade Behring, Inc.2005-05-02
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III (K042494)Ortho-Clinical Diagnostics2004-10-19
IBL C3D-CIC EIA TEST (K032796)Ibl GmbH2004-01-13
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI (K032035)Beckman Coulter, Inc.2003-08-07
TINA-QUANT COMPLEMENT C3C TEST SYSTEM (K012361)Roche Diagnostics Corp.2001-11-29
WAKO AUTOKIT C3 (K010326)Wako Chemicals USA, Inc.2001-06-25
RANDOX COMPLEMENT C3 (K000469)Randox Laboratories, Ltd.2000-03-27
DIMENSION C3 FLEX REAGENT CARTRIDGE (K994296)Dade Behring, Inc.2000-03-01
C3 MININEPH ANTISERUM (K981783)The Binding Site, Ltd.1999-12-20

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