The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Magic Lite Digoxin Immunoassay.
Device ID | K881679 |
510k Number | K881679 |
Device Name: | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
Contact | William J Pignato |
Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
Product Code | DON |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-19 |
Decision Date | 1988-07-08 |