510(k) K003174
K003174 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS DHEA-S". The FDA issued a decision of Substantially Equivalent on January 17, 2001. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2001
- Date Received
- October 10, 2000
- Clearance Type
- Traditional
- 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