The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Calcitonin Immunoradiometric Assay (irma) (coated Tube Version).
| Device ID | K060578 |
| 510k Number | K060578 |
| Device Name: | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) |
| Classification | Radioimmunoassay, Calcitonin |
| 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 | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-06 |
| Decision Date | 2006-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002253153 | K060578 | 000 |