510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822207Substantially Equivalent

2Xc Microscope

Amarel Precision Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822207 is the FDA 510(k) clearance record for 2XC MICROSCOPE, a class I device, cleared for Amarel Precision Instruments, Inc. on under FDA product code IBJ (Light, Microscope). FDA records list one 510(k) clearance for Amarel Precision Instruments, Inc. As of , FDA records show no recalls naming K822207.

Clearance record

Decision date
Received
(13 days to decision)
Product code
IBJ Light, Microscope
Regulation
21 CFR 864.3600
Device class
Class I
Review panel
Pathology
Applicant
Amarel Precision Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IBJ

Trailing 12 months

FDA records hold no clearances under product code IBJ in the trailing twelve months.

FDA records show no clearances under product code IBJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IBJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260