510(k) K972861
K972861 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)". The FDA issued a decision of Substantially Equivalent on August 19, 1997. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1997
- Date Received
- August 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controls For Blood-Gases, (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type