The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Quick-lyte.
| Device ID | K850209 |
| 510k Number | K850209 |
| Device Name: | QUICK-LYTE |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael J Sullivan |
| Correspondent | Michael J Sullivan SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-02-27 |