The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Acs: 180 Ferritin Assay.
| Device ID | K992157 |
| 510k Number | K992157 |
| Device Name: | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414204703 | K992157 | 000 |
| 00630414177151 | K992157 | 000 |
| 00630414177144 | K992157 | 000 |