510(k) K912027
K912027 is an FDA 510(k) premarket notification submitted by Enzyme Technology, Inc. for the device "CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Enzyme Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1992
- Date Received
- May 8, 1991
- 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