510(k) K812872
K812872 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "OPTIONAL TOTAL CA-MODULE FOR IL 504/508". The FDA issued a decision of Substantially Equivalent on October 26, 1981. The device falls under product code CIS (Hydrazone Colorimetry, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1981
- Date Received
- October 14, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hydrazone Colorimetry, Ast/Sgot
- Device Class
- Class II
- Regulation Number
- 862.1100
- Review Panel
- CH
- Submission Type