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510(k) K946050

LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 by Clinical Controls, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
December 12, 1994
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 Clinical Controls, Inc.

  • K012907 — LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL (September 28, 2001)
  • K964278 — WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTRO (November 22, 1996)
  • K962432 — LIQUISPEX URINE (MICRO)ALBUMIN CONTROL (July 5, 1996)
  • K955690 — AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (April 24, 1996)
  • K955691 — SERUM VOLATILES CONTROL LEVEL 1 & 2 (April 24, 1996)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K946049 — LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946048 — LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946266 — FERRITIN CONTROL - LEVEL 1, 2, 3 (February 10, 1995)

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