510(k) K823233

SBA 300 CLINICAL CHEMISTRY ANALYZER by Gilford Instrument Laboratories, Inc. — Product Code JJC

K823233 is an FDA 510(k) premarket notification submitted by Gilford Instrument Laboratories, Inc. for the device "SBA 300 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on November 29, 1982. 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. Gilford Instrument Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
October 29, 1982
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