The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Acth Immunoradiometric (irma) Diagnostic Assay Kit, Model #3kg100.
| Device ID | K021032 |
| 510k Number | K021032 |
| Device Name: | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 |
| Classification | Radioimmunoassay, Acth |
| 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 | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-03 |