The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Autopak Neonatal Tsh Monoclonal Irma Kit.
| Device ID | K871505 |
| 510k Number | K871505 |
| Device Name: | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Contact | Deborah L Lindemuth |
| Correspondent | Deborah L Lindemuth MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-17 |
| Decision Date | 1987-05-26 |