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510(k) K790059

PROACTIVATOR C3, C4 AND C3 by Icl Scientific — Product Code KTP

K790059 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "PROACTIVATOR C3, C4 AND C3". The FDA issued a decision of Substantially Equivalent on March 15, 1979. The device falls under product code KTP (Complement C3b Activator Immunoassay Reagents), a Class II device regulated under 21 CFR 866.5260. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1979
Date Received
January 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3b Activator Immunoassay Reagents
Device Class
Class II
Regulation Number
866.5260
Review Panel
IM
Submission Type

Other clearances by Icl Scientific

  • K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL (November 10, 1988)
  • K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED (October 5, 1984)
  • 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)

FDA data resources