510(k) K182793
K182793 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "AP3600 Automated Instrument". The FDA issued a decision of Substantially Equivalent on Mar 19, 2019. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Hitachi Chemical Diagnostics, Inc. has 15 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 19, 2019
- Date Received
- Oct 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Radioallergosorbent (Rast) Immunological
- Device Class
- Class II
- Regulation Number
- 866.5750
- Review Panel
- IM
- Submission Type
- 510(k)