The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Cyclase Activating Pth (cap) Immunoradiometric (irma) Assay Kit, Model 3kg001.
| Device ID | K031534 |
| 510k Number | K031534 |
| Device Name: | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 |
| 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 | 2003-05-16 |
| Decision Date | 2003-07-30 |