510(k) K820723

KODAK EKTACHEM CLINICAL CHEM. NH3 by Eastman Kodak Company — Product Code JID

K820723 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM CLINICAL CHEM. NH3". The FDA issued a decision of Substantially Equivalent on April 1, 1982. The device falls under product code JID (Photometric Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1982
Date Received
March 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Ammonia
Device Class
Class I
Regulation Number
862.1065
Review Panel
CH
Submission Type