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510(k) K860253

AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) by Amersham Corp. — Product Code CHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
January 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cyclic Amp
Device Class
Class II
Regulation Number
862.1230
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)
  • 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)
  • 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 CHO

  • K844135 — PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU (March 5, 1985)
  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K823504 — CYCLIC ADENOSINE MONOPHOSHATE BY RADIO (January 28, 1983)
  • K811746 — KING DIAGNOSTICS CHOLESTEROL-FE TEST (July 10, 1981)
  • K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] (May 27, 1981)