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510(k) K772075

RADIAL IMMUNODIFFUSION KIT-COMPLEMENT by Gelman Instrument Co. — Product Code DAY

K772075 is an FDA 510(k) premarket notification submitted by Gelman Instrument Co. for the device "RADIAL IMMUNODIFFUSION KIT-COMPLEMENT". The FDA issued a decision of Substantially Equivalent on February 3, 1978. The device falls under product code DAY (Complement C5, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Gelman Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1978
Date Received
November 3, 1977
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 Gelman Instrument Co.

  • K772078 — RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (February 3, 1978)
  • K772080 — RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (February 3, 1978)
  • K772074 — RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN (February 3, 1978)
  • K772079 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (February 3, 1978)
  • K772077 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (February 3, 1978)
  • K772073 — RADIAL IMMUNODIFFUSION KIT-COMP. 3 (February 3, 1978)
  • K772076 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (February 3, 1978)
  • K772325 — DENSITOMETER 18, COMPUTING, AUTO. (January 12, 1978)
  • K771812 — LIPPOPROTEIN ELECTROPHORESIS REAGENT SET (October 18, 1977)
  • K770155 — ALKALINE PHOSPHATASE ISOYZME REAGENT SET (January 31, 1977)

Other clearances for product code DAY

  • K942326 — HUMAN C5 RID KITS (August 24, 1995)
  • K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (April 10, 1995)

FDA data resources