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510(k) K834100

PRE-CALIBRATED PIPETTES by Vitex — Product Code JRC

K834100 is an FDA 510(k) premarket notification submitted by Vitex for the device "PRE-CALIBRATED PIPETTES". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code JRC (Micro Pipette), a Class I device regulated under 21 CFR 862.2050.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 21, 1984
Date Received: November 30, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Micro Pipette
Device Class: Class I
Regulation Number: 862.2050
Review Panel: CH
Submission Type