The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Genetisure Dx Postnatal Assay.
| Device ID | K163367 |
| 510k Number | K163367 |
| Device Name: | GenetiSure Dx Postnatal Assay |
| Classification | System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection |
| Applicant | Agilent Technologies, Inc. 5301 Stevens Creek Blvd. Santa Clara, CA 95051 |
| Contact | Lois Nakayama |
| Correspondent | Bill Kurani Agilent Technologies, Inc. 5301 Stevens Creek Blvd. Santa Clara, CA 95051 |
| Product Code | PFX |
| CFR Regulation Number | 866.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700571112656 | K163367 | 000 |
| 05700571112649 | K163367 | 000 |
| 05700571112632 | K163367 | 000 |
| 05700571112625 | K163367 | 000 |
| 05700571112618 | K163367 | 000 |
| 05700571112601 | K163367 | 000 |
| 05700571108697 | K163367 | 000 |