The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ria-dac Tm Htsh Kih.
| Device ID | K770604 |
| 510k Number | K770604 |
| Device Name: | RIA-DAC TM HTSH KIH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-31 |
| Decision Date | 1977-04-06 |