The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Frt4 Immunoassay.
| Device ID | K961510 |
| 510k Number | K961510 |
| Device Name: | ACS FRT4 IMMUNOASSAY |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-19 |
| Decision Date | 1996-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414294087 | K961510 | 000 |
| 00630414555331 | K961510 | 000 |
| 00630414555324 | K961510 | 000 |
| 00630414555317 | K961510 | 000 |
| 00630414598284 | K961510 | 000 |
| 00630414598277 | K961510 | 000 |