510(k) K944788
K944788 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1995
- Date Received
- September 28, 1994
- 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