510(k) K830700
K830700 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "MMH PTH RIA KIT". The FDA issued a decision of Substantially Equivalent on Apr 6, 1983. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Diagnostic Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 6, 1983
- Date Received
- Mar 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Parathyroid Hormone
- Device Class
- Class II
- Regulation Number
- 862.1545
- Review Panel
- CH
- Submission Type