510(k) K812750
K812750 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL 703, STAT SEPARATOR". The FDA issued a decision of Substantially Equivalent on January 26, 1982. The device falls under product code JRL (Unit, Filter, Membrane), a Class I device regulated under 21 CFR 862.2050. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1982
- Date Received
- September 29, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Filter, Membrane
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type