The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Magic Lite Hcg Immunoassay.
| Device ID | K883927 |
| 510k Number | K883927 |
| Device Name: | CIBA CORNING MAGIC LITE HCG IMMUNOASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-15 |
| Decision Date | 1988-10-13 |