510(k) K770994

FURNACE AUTOSAMPLER, MODEL 155 by Instrumentation Laboratory CO — Product Code DOP

K770994 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "FURNACE AUTOSAMPLER, MODEL 155". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code DOP (Mass Spectrometer, Clinical Use), a Class I device regulated under 21 CFR 862.2860. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1977
Date Received
June 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mass Spectrometer, Clinical Use
Device Class
Class I
Regulation Number
862.2860
Review Panel
TX
Submission Type