510(k) K771468
K771468 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "MULTISTAT III CALCIUM TEST". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code CIA (Methylthymol Blue, Calcium), a Class II device regulated under 21 CFR 862.1145. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1977
- Date Received
- August 4, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methylthymol Blue, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type