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510(k) K183176

Endotoxin Activity Assay (EAA) by Spectral Medical, Inc. — Product Code NGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2019
Date Received
November 16, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Endotoxin Activity, Chemiluminescent
Device Class
Class II
Regulation Number
866.3210
Review Panel
MI
Submission Type

Other clearances by Spectral Medical, Inc.

  • K170790 — SAM CRRT Unit, SAM Cassette CRRT (December 13, 2017)

Other clearances for product code NGS

  • DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (June 16, 2003)