510(k) K860501
K860501 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "FLAME PHOTOMETER STANDARD". The FDA issued a decision of Substantially Equivalent on April 7, 1986. The device falls under product code JLJ (Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate), a Class II device regulated under 21 CFR 862.1315. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1986
- Date Received
- February 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
- Device Class
- Class II
- Regulation Number
- 862.1315
- Review Panel
- CH
- Submission Type