510(k) K841042
K841042 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "MATCHED COMPONENT SET RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Apr 19, 1984. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Cambridge Medical Technology has 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 1984
- Date Received
- Mar 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device Class
- Class I
- Regulation Number
- 862.1680
- Review Panel
- CH
- Submission Type
- 510(k)