The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innofluor (tm) Amikacin Calibrator Set.
| Device ID | K903101 |
| 510k Number | K903101 |
| Device Name: | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET |
| Classification | Calibrators, Drug Specific |
| Applicant | INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
| Contact | Craig Smart |
| Correspondent | Craig Smart INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-13 |
| Decision Date | 1990-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011260 | K903101 | 000 |
| 00884883005686 | K903101 | 000 |