510(k) K832962

GAS CHROMATOGRAPH 5890A by Hewlett-Packard Co. — Product Code KZQ

K832962 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "GAS CHROMATOGRAPH 5890A". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code KZQ (Chromatography(Gas), Clinical Use), a Class I device regulated under 21 CFR 862.2250. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
August 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography(Gas), Clinical Use
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type