510(k) K883269
K883269 is an FDA 510(k) premarket notification submitted by Leeco Diagnostics, Inc. for the device "PRL-QUANT". The FDA issued a decision of Substantially Equivalent on September 13, 1988. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Leeco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1988
- Date Received
- August 3, 1988
- 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