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510(k) K942326

HUMAN C5 RID KITS by Jay H. Geller — Product Code DAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
May 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C5, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Jay H. Geller

  • K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (May 23, 1997)
  • K950015 — HUMAN PROTEIN C RID TEST KIT (March 6, 1995)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (October 5, 1994)

Other clearances for product code DAY

  • K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (April 10, 1995)
  • K772075 — RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (February 3, 1978)