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510(k) K961209

BRIO AUTOMATIC SAMPLINC UNIT by Seac S.R.L. — Product Code JJF

K961209 is an FDA 510(k) premarket notification submitted by Seac S.R.L. for the device "BRIO AUTOMATIC SAMPLINC UNIT". The FDA issued a decision of Substantially Equivalent on December 24, 1996. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1996
Date Received
March 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

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  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K973177 — MAGO AUTOMATED EIA PROCESSOR (October 9, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)

FDA data resources