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510(k) K010500

AUTOMATED WORKCELL CONTROL SOFTWARE by Lab-Interlink, Inc. — Product Code JJE

K010500 is an FDA 510(k) premarket notification submitted by Lab-Interlink, Inc. for the device "AUTOMATED WORKCELL CONTROL SOFTWARE". The FDA issued a decision of Substantially Equivalent on August 1, 2001. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2001
Date Received
February 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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FDA data resources