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510(k) K781024

CERUOPLASMIN SERUM ANTI-HUMAN by Icl Scientific — Product Code DDB

K781024 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "CERUOPLASMIN SERUM ANTI-HUMAN". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code DDB (Ceruloplasmin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5210. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ceruloplasmin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5210
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)

Other clearances for product code DDB

  • K161508 — Ceruloplasmin (January 9, 2017)
  • K122965 — HUMAN CAERULOPLASMIN KIT (June 3, 2013)
  • K053074 — N ANTISERA TO HUMAN CERULOPLASMIN (March 16, 2006)
  • K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (April 25, 1997)
  • K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K895377 — QM300 CERULOPLASMIN ANTIBODY PACK (September 21, 1989)
  • K860138 — NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (March 28, 1986)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K852247 — LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) (July 10, 1985)
  • K851283 — RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN (May 23, 1985)

FDA data resources