510(k) K772337
K772337 is an FDA 510(k) premarket notification submitted by Eppendorf-Brinkmann, Inc. for the device "URINARY 17-KETOSTERIOD/17". The FDA issued a decision of Substantially Equivalent on January 12, 1978. The device falls under product code CDG (Chromatography Separation/Zimmerman 17-Ketogenic Steroids), a Class I device regulated under 21 CFR 862.1385. Eppendorf-Brinkmann, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1978
- Date Received
- December 22, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatography Separation/Zimmerman 17-Ketogenic Steroids
- Device Class
- Class I
- Regulation Number
- 862.1385
- Review Panel
- CH
- Submission Type