510(k) K903130
K903130 is an FDA 510(k) premarket notification submitted by London Diagnostics, Inc. for the device "LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY". The FDA issued a decision of Substantially Equivalent on September 25, 1990. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. London Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1990
- Date Received
- July 17, 1990
- 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