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 |