510(k) K872880
K872880 is an FDA 510(k) premarket notification submitted by Endocrine Associates, Inc. for the device "CALCITONIN RIA KIT". The FDA issued a decision of Substantially Equivalent on August 13, 1987. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Endocrine Associates, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1987
- Date Received
- July 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Calcitonin
- Device Class
- Class II
- Regulation Number
- 862.1140
- Review Panel
- CH
- Submission Type