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510(k) K781016

C3PA (GBG) PROPERDIN FACTOR B by Icl Scientific — Product Code JZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Factor B, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5320
Review Panel
IM
Submission Type

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  • K833761 — THERAPEUTIC DRUG CONTROL (January 13, 1984)
  • K832823 — ENZYMUNE-TEST TSH (October 14, 1983)
  • K831383 — EVENT-TEST SLIDE (June 22, 1983)
  • K823199 — ENZYME-TEST DIGOXIN (November 29, 1982)
  • K822346 — HISTIMUNE ENZYME-ANA TEST (October 8, 1982)
  • K822777 — THERAPEUTIC DRUG CONTROL (October 8, 1982)
  • K822465 — ENZYMUNE SYSTEM I (September 14, 1982)
  • K821374 — ENZYMUNE-TEST INSULIN (May 28, 1982)

Other clearances for product code JZH

  • K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT (March 6, 1997)
  • K882623 — PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (July 8, 1988)
  • K831959 — RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (July 19, 1983)
  • K811740 — KALLESTAD'S ENDOPLATE FACTOR B TEST (July 16, 1981)
  • K772084 — LAS-R HUMAN C3 PROACTIVATOR TEST (January 24, 1978)