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510(k) K772084

LAS-R HUMAN C3 PROACTIVATOR TEST by Hyland Therapeutic Div., Travenol Laboratories — Product Code JZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1978
Date Received
November 4, 1977
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

Other clearances by Hyland Therapeutic Div., Travenol Laboratories

  • K820835 — ALUMINA SILICA-ACTIVATED PARTIAL THROM (April 26, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)
  • K812220 — NEPHELOMETRIC SOLID TURBIDITY STANDARD (August 18, 1981)
  • K810078 — Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (February 2, 1981)
  • K810077 — OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (January 28, 1981)
  • K802610 — ALERT A,HDL-APOLIPOROTEIN A, TEST KIT (January 5, 1981)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790249 — TEST CELLS (May 16, 1979)
  • K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDING (August 31, 1978)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)

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)
  • K781016 — C3PA (GBG) PROPERDIN FACTOR B (August 14, 1978)