510(k) K884480
K884480 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL BILIRUBIN MONOREACTIF". The FDA issued a decision of Substantially Equivalent on November 29, 1988. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1988
- Date Received
- October 25, 1988
- 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