510(k) K894204
K894204 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "CALCIUM (ARSENAZO III) REAGENT". The FDA issued a decision of Substantially Equivalent on Oct 4, 1989. 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 4, 1989
- Date Received
- Jun 19, 1989
- 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)