The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit-amd Amikacin Assay.
Device ID | K822657 |
510k Number | K822657 |
Device Name: | EMIT-AMD AMIKACIN ASSAY |
Classification | Radioimmunoassay, Amikacin |
Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
Contact | Yuk-ting Lewis |
Correspondent | Yuk-ting Lewis DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
Product Code | KLQ |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-03 |
Decision Date | 1982-09-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768001543 | K822657 | 000 |