The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Vancomycin Immunoassay.
| Device ID | K951059 |
| 510k Number | K951059 |
| Device Name: | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | Steven R Rakitin |
| Correspondent | Steven R Rakitin CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-07 |
| Decision Date | 1995-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414443096 | K951059 | 000 |
| 00630414203928 | K951059 | 000 |
| 00630414126111 | K951059 | 000 |
| 00630414121451 | K951059 | 000 |
| 00630414121444 | K951059 | 000 |