510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834100Substantially Equivalent

Pre-Calibrated Pipettes

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

K834100 is the FDA 510(k) clearance record for PRE-CALIBRATED PIPETTES, a class I device, cleared for Vitex on under FDA product code JRC (Micro Pipette). FDA records list one 510(k) clearance for Vitex. As of , FDA records show no recalls naming K834100.

Clearance record

Decision date
Received
(83 days to decision)
Product code
JRC Micro Pipette
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Vitex 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JRC

Trailing 12 months

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

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