510(k) K913833
K913833 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "VENTREX ALLERGEN DISC". The FDA issued a decision of Substantially Equivalent on Feb 21, 1992. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Ventrex Laboratories, Inc. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 1992
- Date Received
- Aug 26, 1991
- 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)