Innofluor Phenytoin Manual Fpia Reagent Set
FDA 510(k) K895827 · Innotron of Oregon, Inc.
510(k) numberK895827
Submission
- Device name
- Innofluor Phenytoin Manual Fpia Reagent Set
- Applicant
- Innotron of Oregon, Inc.
Portland, OR, US - Received
- October 2, 1989
- Decision date
- October 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LGR – Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955873 | Acs Phenytoin AssayLGR · Traditional | Ciba Corning Diagnostics Corp. | 03/11/1996SE |
| K955562 | Innofluor Phenytoin Assay SystemLGR · Traditional | Oxis Intl., Inc. | 01/24/1996SE |
| K953840 | Axsym Phenytoin IILGR · Traditional | Abbott Laboratories | 09/25/1995SE |
| K946328 | Tdx(R)/Tdxflx(R) Phenytoin IILGR · Traditional | Abbott Laboratories | 03/28/1995SE |
| K943313 | Phenytoin Fpia Reagent Set and CalibratorsLGR · Traditional | Sigma Diagnostics, Inc. | 10/27/1994SE |
| K935375 | Axsym Phenytoin AssayLGR · Traditional | Abbott Laboratories | 06/21/1994SE |
| K936131 | Cobas-Fp Reagent for Phenytoin and Coba-Fp Phenytoin CalibratorsLGR · Traditional | Roche Diagnostic Systems, Inc. | 03/11/1994SE |
| K896868 | Opus Phenytoin Test SystemLGR · Traditional | Pb Diagnostic Systems, Inc. | 01/02/1990SE |
| K872563 | Innotron Innofluor Pheytoin Reagent SetLGR · Traditional | Innotron of Oregon, Inc. | 08/21/1987SE |
| K862554 | Immpulse Phenytoin Assay ReagentLGR · Traditional | Sclavo, Inc. | 07/16/1986SE |
More from Sclavo, Inc.
| 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 |
| 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 |
| K895828 | Innofluor Digoxin Reagent SetLCS · Traditional | 10/30/1989SE |
Questions and answers
When was Innofluor Phenytoin Manual Fpia Reagent Set cleared by the FDA?
Innofluor Phenytoin Manual Fpia Reagent Set (K895827) received a 510(k) decision of Substantially Equivalent on October 31, 1989, 29 days after the submission was received.
What is the product code of K895827?
The FDA product code is LGR – Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total), a Class II (moderate risk) device regulated under 21 CFR 862.3350.