The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Low Iionic Strength Solution.
| Device ID | K780413 |
| 510k Number | K780413 |
| Device Name: | LOW IIONIC STRENGTH SOLUTION |
| Classification | Media, Potentiating For In Vitro Diagnostic Use |
| Applicant | PFIZER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSG |
| CFR Regulation Number | 864.9600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-15 |
| Decision Date | 1978-04-24 |