510(k) K770994
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