510(k) K770449
K770449 is an FDA 510(k) premarket notification submitted by Icn Pharmaceuticals, Inc. for the device "CALCIUM PROCEDURE, TEKPOINT DIRECT". The FDA issued a decision of Substantially Equivalent on May 3, 1977. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Icn Pharmaceuticals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1977
- Date Received
- March 8, 1977
- 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