Innofluor (TM) Amikacin Calibrator Set
FDA 510(k) K903101 · Innotron of Oregon, Inc.
510(k) numberK903101
Submission
- Device name
- Innofluor (TM) Amikacin Calibrator Set
- Applicant
- Innotron of Oregon, Inc.
Portland, OR, US - Received
- July 13, 1990
- Decision date
- August 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K052015 | Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108DLJ · Traditional | Dade Behring, Inc. | 09/12/2005SE |
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More from Labone, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903100 | Innofluor (TM) Amikacin Reagent SetKLQ · Traditional | 08/09/1990SE |
| 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 Calibrator Set cleared by the FDA?
Innofluor (TM) Amikacin Calibrator Set (K903101) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 40 days after the submission was received.
What is the product code of K903101?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.