The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Neoscreen Elisa Tsh.
| Device ID | K942658 |
| 510k Number | K942658 |
| Device Name: | NEOSCREEN ELISA TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Nancy Chow |
| Correspondent | Nancy Chow PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1995-02-24 |