The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Certain(r) Elite Level 1, 2 And 3.
| Device ID | K946224 |
| 510k Number | K946224 |
| Device Name: | CERTAIN(R) ELITE LEVEL 1, 2 AND 3 |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | Steven R Rakitin |
| Correspondent | Steven R Rakitin CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-01-30 |