Innotron Fluorimeter Series ONE-10
FDA 510(k) K822942 · Innotron of Oregon, Inc.
510(k) numberK822942
Submission
- Device name
- Innotron Fluorimeter Series ONE-10
- Applicant
- Innotron of Oregon, Inc.
Walker, MI, US - Received
- October 4, 1982
- Decision date
- December 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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| K935047 | Auto DelfiaKHO · Traditional | Wallac OY | 05/23/1994SE |
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More from Tosoh Corp.
| 510(k) | Device | Decision |
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| K903101 | Innofluor (TM) Amikacin Calibrator SetDLJ · Traditional | 08/22/1990SE |
| 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 |
Questions and answers
When was Innotron Fluorimeter Series ONE-10 cleared by the FDA?
Innotron Fluorimeter Series ONE-10 (K822942) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 66 days after the submission was received.
What is the product code of K822942?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.