Home / 510(k) Clearances / K822207

510(k) K822207

2XC MICROSCOPE by Amarel Precision Instruments, Inc. — Product Code IBJ

K822207 is an FDA 510(k) premarket notification submitted by Amarel Precision Instruments, Inc. for the device "2XC MICROSCOPE". The FDA issued a decision of Substantially Equivalent on August 5, 1982. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1982
Date Received
July 23, 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 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)
  • K821865 — A O MICROSCOPE VIDEO SYSTEM (July 14, 1982)
  • K802818 — PULLEN POCKET SCOPE (April 17, 1981)

FDA data resources