510(k) K870369
K870369 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "CALCIUM REAGENT-METHYL THYMOL BLUE METHOD". The FDA issued a decision of Substantially Equivalent on August 19, 1987. The device falls under product code CIA (Methylthymol Blue, Calcium), a Class II device regulated under 21 CFR 862.1145. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1987
- Date Received
- January 28, 1987
- 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