510(k) K941168
K941168 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on September 7, 1994. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Incstar Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1994
- Date Received
- March 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Estradiol
- Device Class
- Class I
- Regulation Number
- 862.1260
- Review Panel
- CH
- Submission Type