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510(k) K942326

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

K942326 is an FDA 510(k) premarket notification submitted by Jay H. Geller for the device "HUMAN C5 RID KITS". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code DAY (Complement C5, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Jay H. Geller has at least 3 other 510(k) clearances on record.

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)

FDA data resources