The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Architect B.r.a.h.m.s Pct, Architect B.r.a.h.m.s Pct Calibrators, Architect B.r.a.h.m.s Pct Controls.
| Device ID | K170652 |
| 510k Number | K170652 |
| Device Name: | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls |
| Classification | Procalcitonin Assay |
| Applicant | Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645 |
| Contact | Connie Yang |
| Correspondent | Kennon Daniels Precision For Medicine 2 Bethesda Metro Center, Suite 850 Bethesda, MD 20814 |
| Product Code | PRI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | PMT |
| Subsequent Product Code | PTF |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-03 |
| Decision Date | 2017-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740139049 | K170652 | 000 |
| 00380740139032 | K170652 | 000 |
| 00380740138912 | K170652 | 000 |
| 00380740138905 | K170652 | 000 |