The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Scantibodies Laboratory Tsh Immunoradiometric Assay (irma)(coated Tube Technology).
| Device ID | K962464 |
| 510k Number | K962464 |
| Device Name: | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) |
| Classification | Radioimmunoassay, Thyroid-stimulating 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-25 |
| Decision Date | 1996-10-08 |