510(k) K984361
K984361 is an FDA 510(k) premarket notification submitted by Osborn Laboratories, Inc. for the device "ORAL-EZE ORAL FLUID COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 13, 1999. The device falls under product code PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device), a Class II device regulated under 21 CFR 862.1675. Osborn Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1999
- Date Received
- December 7, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.