510(k) K952647
K952647 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST LIPASE". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1995
- Date Received
- June 9, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipase-Esterase, Enzymatic, Photometric, Lipase
- Device Class
- Class I
- Regulation Number
- 862.1465
- Review Panel
- CH
- Submission Type