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510(k) K772325

DENSITOMETER 18, COMPUTING, AUTO. by Gelman Instrument Co. — Product Code JQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1978
Date Received
December 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class
Class I
Regulation Number
862.2400
Review Panel
CH
Submission Type

Other clearances by Gelman Instrument Co.

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  • K772075 — RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (February 3, 1978)
  • K772076 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (February 3, 1978)
  • K772078 — RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (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)
  • K771812 — LIPPOPROTEIN ELECTROPHORESIS REAGENT SET (October 18, 1977)
  • K770155 — ALKALINE PHOSPHATASE ISOYZME REAGENT SET (January 31, 1977)

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