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510(k) K142132

POOL NORM by Diagnostics Stago S.A.S. — Product Code GGN

K142132 is an FDA 510(k) premarket notification submitted by Diagnostics Stago S.A.S. for the device "POOL NORM". The FDA issued a decision of Substantially Equivalent on December 12, 2014. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
August 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)
  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)

FDA data resources