510(k) K880949
K880949 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Methods, Inc. for the device "SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER". The FDA issued a decision of Substantially Equivalent on April 5, 1988. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Advanced Biomedical Methods, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1988
- Date Received
- March 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Azo Dye, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type