510(k) K771068
K771068 is an FDA 510(k) premarket notification submitted by Environmental Chemical Specialties for the device "TRIGLYCERIDE KIT". The FDA issued a decision of Substantially Equivalent on July 12, 1977. The device falls under product code JGM (Flame Photometry, Potassium), a Class II device regulated under 21 CFR 862.1600. Environmental Chemical Specialties has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1977
- Date Received
- June 13, 1977
- 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