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510(k) K001468

ELECSYS CA 15-3 TEST SYSTEM by Roche Diagnostics Corp. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2000
Date Received
May 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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  • K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALI (April 18, 2011)
  • K072612 — ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 3876 (October 26, 2007)
  • K042732 — ARCHITECT CA 15-3 ASSAY (December 22, 2004)