510(k) K801290

ALIZARIN SULFONATE, CALCIUM by Union Carbide Corp. — Product Code CID

K801290 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "ALIZARIN SULFONATE, CALCIUM". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code CID (Alizarin Sulfonate, Calcium), a Class II device regulated under 21 CFR 862.1145. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1980
Date Received
May 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alizarin Sulfonate, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type