510(k) K930304
K930304 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS CORE FSH EIA". The FDA issued a decision of Substantially Equivalent on September 21, 1993. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1993
- Date Received
- January 21, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Follicle-Stimulating Hormone
- Device Class
- Class I
- Regulation Number
- 862.1300
- Review Panel
- CH
- Submission Type