Innofluor (TM) Amikacin Reagent Set
FDA 510(k) K903100 · Innotron of Oregon, Inc.
510(k) numberK903100
Submission
- Device name
- Innofluor (TM) Amikacin Reagent Set
- Applicant
- Innotron of Oregon, Inc.
Portland, OR, US - Received
- July 13, 1990
- Decision date
- August 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLQ – Radioimmunoassay, Amikacin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3035
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | Seradyn, Inc. | 11/01/2005SE |
| K033884 | Randox AmikacinKLQ · Traditional | Randox Laboratories, Ltd. | 06/09/2004SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | Oxis Intl., Inc. | 02/09/1996SE |
| K894517 | FPR Amikacin KitKLQ · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K852317 | Cobas FP Reagen for Amikacin & Amikacin CalibratorKLQ · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| K843211 | Amikacin Analytical Test Pack AcaKLQ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/12/1984SE |
| K841161 | Immpulse Amikacin Assay ReagentsKLQ · Traditional | Paragon Diagnostics, Inc. | 05/02/1984SE |
| K840193 | Emit QST Amikacin AssayKLQ · Traditional | Syva Co. | 03/23/1984SE |
| K832336 | Stratus Amikacin FluorometricKLQ · Traditional | American Dade | 08/31/1983SE |
| K822657 | Emit-Amd Amikacin AssayKLQ · Traditional | Dade Behring, Inc. | 09/28/1982SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903101 | Innofluor (TM) Amikacin Calibrator SetDLJ · Traditional | 08/22/1990SE |
| K900707 | Modified Accufluor Tobramycin Reagent & CalibratorLFW · Traditional | 04/20/1990SE |
| K900708 | Modified Accufluor Vancomycin Reagent & CalibratorLEH · Traditional | 04/19/1990SE |
| K900706 | Modified Accufluor Theophylline Reagent & CalibraLGS · Traditional | 04/12/1990SE |
| K900705 | Modified Accufluor Quinidine Reagent & CalibratorLBZ · Traditional | 04/12/1990SE |
| K900704 | Modified Accufluor Phenobarbital Reagent & CalibraLGQ · Traditional | 04/12/1990SE |
| K900703 | Modified Accufluor Gentamicin Reagent & CalibratorLCD · Traditional | 04/12/1990SE |
| K900702 | Modified Accufluor Carbamazepine Reagent & CalibraLGI · Traditional | 04/12/1990SE |
| K895827 | Innofluor Phenytoin Manual Fpia Reagent SetLGR · Traditional | 10/31/1989SE |
| K895828 | Innofluor Digoxin Reagent SetLCS · Traditional | 10/30/1989SE |
Questions and answers
When was Innofluor (TM) Amikacin Reagent Set cleared by the FDA?
Innofluor (TM) Amikacin Reagent Set (K903100) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 27 days after the submission was received.
What is the product code of K903100?
The FDA product code is KLQ – Radioimmunoassay, Amikacin, a Class II (moderate risk) device regulated under 21 CFR 862.3035.