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510(k) K821865

A O MICROSCOPE VIDEO SYSTEM by Warner-Lambert Co. — Product Code IBJ

K821865 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "A O MICROSCOPE VIDEO SYSTEM". The FDA issued a decision of Substantially Equivalent on July 14, 1982. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1982
Date Received
June 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Microscope
Device Class
Class I
Regulation Number
864.3600
Review Panel
PA
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)
  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC 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)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)

Other clearances for product code IBJ

  • K874750 — VIDEO ANALYZER 4000 (April 25, 1988)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 1985)
  • K823040 — PATHOLOGY INSTRUMENTATION & ACCESSORIES (January 14, 1983)
  • K822207 — 2XC MICROSCOPE (August 5, 1982)
  • K802818 — PULLEN POCKET SCOPE (April 17, 1981)

FDA data resources