510(k) K831300
K831300 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "MSI-NAK-50 TEST KIT". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code JGM (Flame Photometry, Potassium), a Class II device regulated under 21 CFR 862.1600. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1983
- Date Received
- April 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flame Photometry, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type