Modified Accufluor Vancomycin Reagent & Calibrator
FDA 510(k) K900708 · Innotron of Oregon, Inc.
510(k) numberK900708
Submission
- Device name
- Modified Accufluor Vancomycin Reagent & Calibrator
- Applicant
- Innotron of Oregon, Inc.
Portland, OR, US - Received
- February 12, 1990
- Decision date
- April 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LEH – Radioimmunoassay, Vancomycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3950
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)LEH · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/08/2023SE |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)LEH · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/27/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | Roche Diagnostics Operations (Rdo) | 01/08/2016SE |
| K123947 | Architect IvancomycinLEH · Traditional | Biokit, S.A. | 08/29/2013SE |
| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…LEH · Traditional | Biokit, S.A. | 03/19/2008SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | Diagnostic Products Corp. | 12/05/2006SE |
| K060586 | Enzyme Immunoassay, VancomycinLEH · Traditional | Roche Diagnostics Corp. | 05/11/2006SE |
| K050419 | QMS VancomycinLEH · Traditional | Seradyn, Inc. | 04/01/2005SE |
| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…LEH · Traditional | Ortho-Clinical Diagnostics, Inc. | 02/07/2005SE |
| K032811 | Cedia Vancomycin AssayLEH · Traditional | Microgenics Corp. | 11/24/2003SE |
More from Microgenics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 Modified Accufluor Vancomycin Reagent & Calibrator cleared by the FDA?
Modified Accufluor Vancomycin Reagent & Calibrator (K900708) received a 510(k) decision of Substantially Equivalent on April 19, 1990, 66 days after the submission was received.
What is the product code of K900708?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.