510(k) K812777

DIRECT IRON REAGENT SET by The Dow Chemical Co. — Product Code JIY

K812777 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "DIRECT IRON REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 19, 1981. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1981
Date Received
October 5, 1981
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