The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Lsd Assay.
Device ID | K955814 |
510k Number | K955814 |
Device Name: | CEDIA DAU LSD ASSAY |
Classification | Radioimmunoassay, Lsd (125-i) |
Applicant | MICROGENICS CORP. 2380 A BISSO LN. Concord, CA 94520 |
Contact | Mary Koning |
Correspondent | Mary Koning MICROGENICS CORP. 2380 A BISSO LN. Concord, CA 94520 |
Product Code | DLB |
CFR Regulation Number | 862.3580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-26 |
Decision Date | 1996-02-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884883005679 | K955814 | 000 |