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510(k) K812235

GOLD(AU 195) SPOT MARKER SOURCES by Amersham Corp. — Product Code IXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
August 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Calibration, Sealed, Nuclear
Device Class
Class I
Regulation Number
892.1400
Review Panel
RA
Submission Type

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  • K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) (July 9, 1990)
  • K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 (July 9, 1990)
  • K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) (July 9, 1990)
  • K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (December 12, 1989)

Other clearances for product code IXD

  • K850208 — FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS (March 26, 1985)