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 |