510(k) K940271
K940271 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "INCSTAR ACTH IRMA". The FDA issued a decision of Substantially Equivalent on August 2, 1994. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Incstar Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1994
- Date Received
- January 21, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Acth
- Device Class
- Class II
- Regulation Number
- 862.1025
- Review Panel
- CH
- Submission Type