Home / 510(k) Clearances / K973933

510(k) K973933

SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 by Diagnostic Chemicals , Ltd. — Product Code JIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1997
Date Received
October 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

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