The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Abbott Phenobarbital Assay.
Device ID | K123271 |
510k Number | K123271 |
Device Name: | ABBOTT PHENOBARBITAL ASSAY |
Classification | Enzyme Immunoassay, Phenobarbital |
Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
Contact | Karen Lee |
Correspondent | Karen Lee MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
Product Code | DLZ |
CFR Regulation Number | 862.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-19 |
Decision Date | 2013-04-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00380740154110 | K123271 | 000 |
00380740102692 | K123271 | 000 |