The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Intact Pth Immunoradiometric (irma) Assay (coated Bead-technology).
| Device ID | K944788 |
| 510k Number | K944788 |
| Device Name: | INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-28 |
| Decision Date | 1995-07-19 |