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ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211

FDA 510(k) clearance K981354 · decided 1998-05-01

Clearance details

K-number
K981354
Device name
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
Applicant
Beckman Instruments, Inc.
Decision
Substantially Equivalent
Date received
1998-04-14
Decision date
1998-05-01
Days to decision
17 days
Clearance type
Traditional
Product code
LOJ
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Chaska, MN, 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.

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VIDAS AFP ASSAY (K080017)bioMerieux, Inc.2008-09-26
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 (K071597)Dade Behring, Inc.2008-06-04
ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894)Tosoh Medics, Inc.2002-12-17
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806)Bayer Corp.2002-03-27
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138)Diagnostic Systems Laboratories, Inc.1999-06-21
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031)Ortho-Clinical Diagnostics, Inc.1998-12-18
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263)Diagnostic Products Corp.1998-12-07

Recalls involving this device

RecordFirmDate
Access Immunoassay Systems Assay Protocol: Dil-AFP. recall (Z-1388-05)Beckman Coulter Inc2005-08-23