510(k) K911059

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

K911059 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "TURBIDOMETRIC STANDARD". The FDA issued a decision of Substantially Equivalent on June 10, 1991. The device falls under product code LIE (Reagent/Device, Inoculum Calibration), a Class II device regulated under 21 CFR 866.1640. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

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