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510(k) K922722

TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL by Simplicity Diagnostics, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
June 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Simplicity Diagnostics, Inc.

  • K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER (March 10, 1997)
  • K922725 — TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL (October 5, 1992)
  • K922726 — TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL (October 5, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)

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