The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Modification To: Total Intact Pth Immunochemiluminometric (icma) Assay Kit.
| Device ID | K060348 |
| 510k Number | K060348 |
| Device Name: | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Contact | Michael Nordstrom |
| Correspondent | Michael Nordstrom SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-10 |
| Decision Date | 2006-02-27 |
| Summary: | summary |