510(k) K823577
K823577 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "COBAS REAGENT FOR CALCIUM". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1983
- Date Received
- December 6, 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