510(k) K980757
K980757 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ILAB 600 CLINICAL CHEMISTRY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1998. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1998
- Date Received
- February 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion-Specific, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type