Home / 510(k) Clearances / K946265

510(k) K946265

FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 by Clinical Controls, Inc. — Product Code GIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
December 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Fibrinogen Control
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
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)
  • K955691 — SERUM VOLATILES CONTROL LEVEL 1 & 2 (April 24, 1996)
  • K955690 — AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (April 24, 1996)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K946266 — FERRITIN CONTROL - LEVEL 1, 2, 3 (February 10, 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)
  • K946050 — LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 (February 10, 1995)

Other clearances for product code GIL

  • K962407 — N/T PROTEIN CONTROL PY (July 29, 1996)
  • K946193 — FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K951012 — N/T PROTEIN CONTROL PY (April 17, 1995)
  • K934741 — LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (September 8, 1994)
  • K915462 — FIBRINOGEN CONTROL (March 4, 1992)
  • K833352 — GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL (November 3, 1983)