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510(k) K772077

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G by Gelman Instrument Co. — Product Code DEW

K772077 is an FDA 510(k) premarket notification submitted by Gelman Instrument Co. for the device "RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G". The FDA issued a decision of Substantially Equivalent on February 3, 1978. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. 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
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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)
  • K772075 — RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (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 DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources