510(k) K132462
K132462 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE". The FDA issued a decision of Substantially Equivalent on October 28, 2013. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2013
- Date Received
- August 7, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urease, Photometric, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type