510(k) K971967
K971967 is an FDA 510(k) premarket notification submitted by Carolina Liquid Chemistries Corp. for the device "BUN". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Carolina Liquid Chemistries Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1997
- Date Received
- May 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type