510(k) K930305
K930305 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS CORE PROLACTIN EIA". The FDA issued a decision of Substantially Equivalent on August 19, 1993. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1993
- Date Received
- January 21, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Prolactin (Lactogen)
- Device Class
- Class I
- Regulation Number
- 862.1625
- Review Panel
- CH
- Submission Type