510(k) K965094
K965094 is an FDA 510(k) premarket notification submitted by Hycor Biomedical, Inc. for the device "HYCOR ALLERGEN DISC". The FDA issued a decision of Substantially Equivalent on May 21, 1997. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Hycor Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1997
- Date Received
- December 19, 1996
- 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