510(k) K901673
K901673 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PROLACTIN (LACTOGEN) TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 12, 1990. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 12, 1990
- Date Received
- Apr 10, 1990
- 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
- 510(k) Exempt