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510(k) K970087

CR PERFECT by Chimera Research & Chemical, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
January 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Chimera Research & Chemical, Inc.

  • K951877 — AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE (May 14, 1996)
  • K953393 — TOX PERFECT A TUBE (October 6, 1995)
  • 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)

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