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510(k) K890414

RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) by Amersham Corp. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
January 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Amersham Corp.

  • K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (February 18, 1992)
  • K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (July 22, 1991)
  • K912766 — AMERLITE CK-MB ASSAY (July 17, 1991)
  • K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (November 2, 1990)
  • K902760 — AMERSHAM TSH CONTROL SERA (July 27, 1990)
  • K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) (July 9, 1990)
  • K901848 — GADOLINIUM-153 BONE DENSITOMETER SOURCES (July 9, 1990)
  • K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) (July 9, 1990)
  • K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 (July 9, 1990)
  • K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (December 12, 1989)

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