510(k) K862605

MODULAR MASS SPECTROMETER (M.S.) by The Perkin-Elmer Corp. — Product Code CCK

K862605 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "MODULAR MASS SPECTROMETER (M.S.)". The FDA issued a decision of Substantially Equivalent on August 13, 1986. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1986
Date Received
July 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type