Cleared Traditional

K834100 - PRE-CALIBRATED PIPETTES
(FDA 510(k) Clearance)

K834100 · Vitex · Chemistry device

Feb 1984

Decision

83d

Days

Class 1

Risk

K834100 is an FDA 510(k) clearance for the PRE-CALIBRATED PIPETTES. This device is classified as a Micro Pipette (Class I - General Controls, product code JRC).

Submitted by Vitex (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984, 83 days after receiving the submission on November 30, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K834100 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 30, 1983
Decision Date	February 21, 1984
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—