The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Acs: 180 Ft3.
| Device ID | K991692 |
| 510k Number | K991692 |
| Device Name: | CHIRON DIAGNOSTICS ACS: 180 FT3 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| 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 | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-18 |
| Decision Date | 1999-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599106 | K991692 | 000 |
| 00630414599090 | K991692 | 000 |
| 00630414599083 | K991692 | 000 |
| 00630414209050 | K991692 | 000 |
| 00630414207537 | K991692 | 000 |
| 00630414207520 | K991692 | 000 |
| 00630414126289 | K991692 | 000 |
| 00630414294186 | K991692 | 000 |