The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit 2000 Cyclosporine Specific Assay.
Device ID | K053061 |
510k Number | K053061 |
Device Name: | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
Classification | Cyclosporine |
Applicant | DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
Contact | Yuk-ting Lewis |
Correspondent | Yuk-ting Lewis DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
Product Code | MKW |
CFR Regulation Number | 862.1235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-31 |
Decision Date | 2006-02-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768001451 | K053061 | 000 |