510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832011Substantially Equivalent

Ameri Clear

Stephens Scientific, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832011 is the FDA 510(k) clearance record for AMERI CLEAR, a class I device, cleared for Stephens Scientific on under FDA product code KEM (Agent, Clearing). FDA records list 4 510(k) clearances for Stephens Scientific, from to . As of , FDA records show no recalls naming K832011.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KEM Agent, Clearing
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Stephens Scientific 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEM

Trailing 12 months

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

FDA records show no clearances under product code KEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KEM, 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