510(k) K851514
K851514 is an FDA 510(k) premarket notification submitted by Bio-Analytics Laboratories, Inc. for the device "ULTRA-VIOLET GLUCOSE REAGENT". The FDA issued a decision of Substantially Equivalent on May 20, 1985. The device falls under product code CFA (Electrode, Ion Specific, Magnesium), a Class I device regulated under 21 CFR 862.1495. Bio-Analytics Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1985
- Date Received
- April 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Magnesium
- Device Class
- Class I
- Regulation Number
- 862.1495
- Review Panel
- CH
- Submission Type