510(k) K911059

TURBIDOMETRIC STANDARD by Scientific Device Laboratory, Inc. — Product Code LIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent/Device, Inoculum Calibration
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type