510(k) K963536
K963536 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS CALICIUM REAGENT". The FDA issued a decision of Substantially Equivalent on Oct 10, 1996. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 10, 1996
- Date Received
- Sep 3, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Azo Dye, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type
- 510(k)