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510(k) K781017

ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) by Icl Scientific — Product Code DBA

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
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5250
Review Panel
IM
Submission Type

Other clearances by Icl Scientific

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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 DBA

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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)
  • K011780 — K-ASSAY C1-INA (July 25, 2001)
  • K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE (March 19, 2001)
  • K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KIT (July 14, 1997)
  • K960257 — N ANTISERUM TO C1 INHIBITOR (August 1, 1996)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K915431 — COMPLEMENT C1 INACTIVATOR KIT (January 17, 1992)
  • K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (July 23, 1987)