510(k) K920419
K920419 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST DAT CAL/CONTROL SET D/E". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code DLG (Coating, Liquid, Glc), a Class I device regulated under 21 CFR 862.2250. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1992
- Date Received
- January 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Liquid, Glc
- Device Class
- Class I
- Regulation Number
- 862.2250
- Review Panel
- TX
- Submission Type