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510(k) K963803

CENTOCOR CA 15-3 RIA MODEL NO. 800-033 by Centocor, Inc. — Product Code MOI

K963803 is an FDA 510(k) premarket notification submitted by Centocor, Inc. for the device "CENTOCOR CA 15-3 RIA MODEL NO. 800-033". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Centocor, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1997
Date Received
September 23, 1996
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

Other clearances by Centocor, Inc.

  • K954997 — CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT (January 24, 1996)
  • K820499 — FITC ANTI-RABIES MONOCLONAL GLOBULIN (April 16, 1982)

Other clearances for product code MOI

  • K240403 — Access BR Monitor (May 9, 2024)
  • K233946 — IMMULITE® 2000 BR-MA (March 13, 2024)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K193489 — ADVIA Centaur BR (February 13, 2020)
  • K192777 — ADVIA Centaur CA 15-3 assay (November 22, 2019)
  • K181492 — Elecsys CA 15-3 II (June 22, 2018)
  • K171605 — Elecsys CA 15-3 II (February 20, 2018)
  • 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)

FDA data resources