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510(k) K803272

AUTOMATED IMMUNOPRECIPITIN METHOD/ICG by Icl Scientific — Product Code DFZ

K803272 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "AUTOMATED IMMUNOPRECIPITIN METHOD/ICG". The FDA issued a decision of Substantially Equivalent on January 26, 1981. The device falls under product code DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1981
Date Received
December 29, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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)
  • K822777 — THERAPEUTIC DRUG CONTROL (October 8, 1982)
  • K822346 — HISTIMUNE ENZYME-ANA TEST (October 8, 1982)
  • K822465 — ENZYMUNE SYSTEM I (September 14, 1982)
  • K821374 — ENZYMUNE-TEST INSULIN (May 28, 1982)

Other clearances for product code DFZ

  • K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION (October 21, 2009)
  • K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIME (June 17, 2002)
  • K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (May 14, 2002)
  • K955906 — BOEHRINGER MANNHEIM IGG ASSAY (February 9, 1996)
  • K940422 — IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALY (May 27, 1994)
  • K812821 — H-103 IGG, H-104 IGA, H-105 IGM (October 26, 1981)
  • K790720 — ANTISERA TO RABBIT IMMUNOGLOBULIN (August 16, 1979)
  • K790709 — ANTISERUM TO RABBIT IMMUNOGLOBULIN (August 16, 1979)

FDA data resources