510(k) K881056

AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 by American Research Products Co. — Product Code JJC

K881056 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030". The FDA issued a decision of Substantially Equivalent on November 15, 1988. The device falls under product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use), a Class I device regulated under 21 CFR 862.2150. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1988
Date Received
March 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type