510(k) K040181
K040181 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS DHEA-S REAGENT ASSAY". The FDA issued a decision of Substantially Equivalent on March 24, 2004. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2004
- Date Received
- January 27, 2004
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- Device Class
- Class I
- Regulation Number
- 862.1245
- Review Panel
- CH
- Submission Type