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510(k) K772076

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

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
Iga, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Gelman Instrument Co.

  • K772077 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (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)
  • K772080 — RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (February 3, 1978)
  • K772079 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (February 3, 1978)
  • K772078 — RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (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 CZP

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  • K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (February 13, 2006)
  • K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (March 10, 2004)
  • K024038 — N LATEX IGA (February 13, 2003)
  • K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (January 14, 2000)
  • K983359 — IGA (November 4, 1998)
  • K962200 — QUANTEX IGA (September 25, 1996)
  • K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K955907 — BOEHRINGER MANNHEIM IGA ASSAY (February 9, 1996)
  • K952309 — N LATEX IGA (June 20, 1995)