510(k) K823480
K823480 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL 943 FLAME PHOTOMETER". The FDA issued a decision of Substantially Equivalent on January 9, 1983. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1983
- Date Received
- November 23, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flame Emission Photometer For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2540
- Review Panel
- CH
- Submission Type