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510(k) K953393

TOX PERFECT A TUBE by Chimera Research & Chemical, Inc. — Product Code DMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1995
Date Received
July 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digoxin Control Serum, Ria
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Chimera Research & Chemical, Inc.

  • K970087 — CR PERFECT (March 6, 1997)
  • K951877 — AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE (May 14, 1996)
  • K952501 — TOX PERFECT B TUBES AND REAGENTS (August 24, 1995)
  • K950142 — CR PERFECT (May 25, 1995)
  • K940768 — AD PERFECT (February 17, 1995)
  • K935408 — UA PERFECT (June 13, 1994)

Other clearances for product code DMP

  • K973973 — ELECSYS CALLCHECK DIGOXIN (November 4, 1997)
  • K780889 — DIGOXIN STANDARDS IN HUMAN SERUM (August 14, 1978)
  • K770411 — DIGI TROL TM-RX & DIGI TROL TM-TX (March 16, 1977)