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510(k) K772079

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M by Gelman Instrument Co. — Product Code DFL

K772079 is an FDA 510(k) premarket notification submitted by Gelman Instrument Co. for the device "RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M". The FDA issued a decision of Substantially Equivalent on February 3, 1978. The device falls under product code DFL (Igm, Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. 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
Igm, Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Gelman Instrument Co.

  • K772076 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (February 3, 1978)
  • K772080 — RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (February 3, 1978)
  • K772074 — RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN (February 3, 1978)
  • K772075 — RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (February 3, 1978)
  • K772073 — RADIAL IMMUNODIFFUSION KIT-COMP. 3 (February 3, 1978)
  • K772078 — RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (February 3, 1978)
  • K772077 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (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 DFL

  • K883493 — TECHNICON DPA-1 IMMUNOGLOBULIN M (September 22, 1988)
  • K882822 — FIAGEN FERRITIN (August 4, 1988)

FDA data resources