510(k) K770871
K770871 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRAZYME PLUS HBD". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase), a Class I device regulated under 21 CFR 862.1380. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1977
- Date Received
- May 13, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
- Device Class
- Class I
- Regulation Number
- 862.1380
- Review Panel
- CH
- Submission Type