The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Acs Digitoxin.
| Device ID | K970546 |
| 510k Number | K970546 |
| Device Name: | ACS DIGITOXIN |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-12 |
| Decision Date | 1997-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598789 | K970546 | 000 |
| 00630414598772 | K970546 | 000 |
| 00630414207414 | K970546 | 000 |
| 00630414203935 | K970546 | 000 |