510(k) K955025
K955025 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM PROGESTERONE". The FDA issued a decision of Substantially Equivalent on March 7, 1996. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1996
- Date Received
- November 2, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Progesterone
- Device Class
- Class I
- Regulation Number
- 862.1620
- Review Panel
- CH
- Submission Type