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510(k) K833352

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL by Warner-Lambert Co. — Product Code GIL

K833352 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code GIL (Plasma, Fibrinogen Control), a Class II device regulated under 21 CFR 864.7340. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
September 28, 1983
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 Warner-Lambert Co.

  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K893452 — EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM (June 22, 1989)
  • K870584 — O.P.T.(TM) OVULATION PREDICTION TEST (November 25, 1987)
  • K861510 — MULTILUMEN VIAPIC CENTRAL LINE CATHETER (June 9, 1986)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (August 19, 1985)
  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K852889 — GENERAL DIAGNOSTICS RAPID E. COLI TEST (July 23, 1985)
  • K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (May 8, 1985)
  • K850412 — GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY (May 8, 1985)

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)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 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)

FDA data resources