510(k) K000043
K000043 is an FDA 510(k) premarket notification submitted by Drg Intl., Inc. for the device "DRG AURICA ELISA TESTOSTERONE KIT". The FDA issued a decision of Substantially Equivalent on April 17, 2000. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Drg Intl., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2000
- Date Received
- January 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device Class
- Class I
- Regulation Number
- 862.1680
- Review Panel
- CH
- Submission Type