510(k) K901702

NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 by American Research Products Co. — Product Code CKA

K901702 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522". The FDA issued a decision of Substantially Equivalent on April 25, 1990. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
April 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type