The following data is part of a premarket notification filed by Neo-genesis with the FDA for Accuwell 17-alpha-hydroxyproesterone Enzyme Immunoassay With Models 6015xx-ecah.
| Device ID | K060452 |
| 510k Number | K060452 |
| Device Name: | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | NEO-GENESIS 4814 N.E. 107TH AVENUE Portland, OR 97220 |
| Contact | Jannet Baldwin |
| Correspondent | Jannet Baldwin NEO-GENESIS 4814 N.E. 107TH AVENUE Portland, OR 97220 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2007-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000625 | K060452 | 000 |