The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Dau I, Dau Ii, Dau Iii And Dau Iv Control Urine.
| Device ID | K893835 |
| 510k Number | K893835 |
| Device Name: | DAU I, DAU II, DAU III AND DAU IV CONTROL URINE |
| Classification | Drug Mixture Control Materials |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | D Schaefer |
| Correspondent | D Schaefer CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-24 |
| Decision Date | 1989-07-25 |