The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Immunohematological Saline #97139.
| Device ID | K831200 |
| 510k Number | K831200 |
| Device Name: | IMMUNOHEMATOLOGICAL SALINE #97139 |
| Classification | Solution, Isotonic |
| Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCE |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-11 |
| Decision Date | 1983-05-09 |