The following data is part of a premarket notification filed by Environmental Sciences Assoc., Inc. with the FDA for Analyzer, Serum Iron & Total Iron Bindin.
| Device ID | K781009 |
| 510k Number | K781009 |
| Device Name: | ANALYZER, SERUM IRON & TOTAL IRON BINDIN |
| Classification | Radioimmunoassay, Total Estrogens, Nonpregnancy |
| Applicant | ENVIRONMENTAL SCIENCES ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMD |
| CFR Regulation Number | 862.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-19 |
| Decision Date | 1978-07-27 |