510(k) K823756
K823756 is an FDA 510(k) premarket notification submitted by Em Industries, Inc. for the device "ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082". The FDA issued a decision of Substantially Equivalent on January 12, 1983. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Em Industries, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1983
- Date Received
- December 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cresolphthalein Complexone, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type