FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

PRE-CALIBRATED PIPETTES

K Number: K834100 · Decision Feb 21, 1984
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
5
Applicant Total
1
Review Days
83

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Basic Information

Device Name
PRE-CALIBRATED PIPETTES
K Number
K834100
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2050
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Vitex
Date Received
November 30, 1983
Decision Date
February 21, 1984
Product Code
JRC
Advisory Committee
Clinical Chemistry
Review Advisory Committee
CH
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JRC Micro Pipette

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