The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Quick Chem Ii.
| Device ID | K901695 |
| 510k Number | K901695 |
| Device Name: | QUICK CHEM II |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | J Sullivan |
| Correspondent | J Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-10 |
| Decision Date | 1990-05-24 |