510(k) K883327
K883327 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST". The FDA issued a decision of Substantially Equivalent on January 23, 1989. The device falls under product code JGZ (O-Phthalaldehyde, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1989
- Date Received
- August 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- O-Phthalaldehyde, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type