The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Acs:180tu P.
| Device ID | K970539 |
| 510k Number | K970539 |
| Device Name: | CHIRON DIAGNOSTICS ACS:180TU P |
| Classification | Radioassay, Triiodothyronine Uptake |
| 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 | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-12 |
| Decision Date | 1997-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600253 | K970539 | 000 |
| 00630414600246 | K970539 | 000 |
| 00630414177137 | K970539 | 000 |
| 00630414177120 | K970539 | 000 |