The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl-5300 Tsh Immunoradiometric Assay (irma) Kit.
| Device ID | K864133 |
| 510k Number | K864133 |
| Device Name: | DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Gopal Savjani |
| Correspondent | Gopal Savjani DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1986-12-18 |