The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Total Ige Immunoassay.
| Device ID | K920372 |
| 510k Number | K920372 |
| Device Name: | ACS TOTAL IGE IMMUNOASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| 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 | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-28 |
| Decision Date | 1992-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599397 | K920372 | 000 |
| 00630414599380 | K920372 | 000 |
| 00630414599373 | K920372 | 000 |
| 00630414177489 | K920372 | 000 |
| 00630414177472 | K920372 | 000 |
| 00630414175331 | K920372 | 000 |