Bio-Rad Laboratories, Inc. · Class I · Cleared Feb 25, 1997
| K-number | K970126 |
| Device name | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) |
| Applicant | Bio-Rad Laboratories, Inc. |
| Product code | CHP |
| Device class | Class I |
| Decision date | Feb 25, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.1260 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov