510(k) K910697
K910697 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL THEOPHYLLINE ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 3, 1991. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1991
- Date Received
- February 19, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Theophylline
- Device Class
- Class II
- Regulation Number
- 862.3880
- Review Panel
- TX
- Submission Type