The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Acth Immunoradiometric (irma) Assay Kit, Model 3kg011.
| Device ID | K050748 |
| 510k Number | K050748 |
| Device Name: | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 |
| Classification | Radioimmunoassay, Acth |
| 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 | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-22 |
| Decision Date | 2005-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002253160 | K050748 | 000 |