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 |