Modification of Tricyclic Serum Tox Eia Assay
FDA 510(k) K983268 · Diagnostic Reagents, Inc.
510(k) numberK983268
Submission
- Device name
- Modification of Tricyclic Serum Tox Eia Assay
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- September 17, 1998
- Decision date
- November 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFH – U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | Microgenics Corporation | 11/17/2023SE |
| K213875 | DRI TM Tricyclics Serum Tox AssayLFH · Traditional | Microgenics Corporation | 12/21/2022SE |
| K981801 | Accusign Tca, Biosign Tca, Staus DS TcaLFH · Traditional | Princeton BioMeditech Corp. | 08/25/1998SE |
| K961393 | Tricyclics Serum Tox AssayLFH · Traditional | Diagnostic Reagents, Inc. | 06/12/1996SE |
| K953761 | Axsym Tricyclic AntidepressantsLFH · Traditional | Abbott Laboratories | 11/22/1995SE |
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|---|---|---|
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
| K962463 | Procainamide Enzyme ImmunoassayLAR · Traditional | 08/14/1996SE |
Questions and answers
When was Modification of Tricyclic Serum Tox Eia Assay cleared by the FDA?
Modification of Tricyclic Serum Tox Eia Assay (K983268) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 62 days after the submission was received.
What is the product code of K983268?
The FDA product code is LFH – U.V. Spectrometry, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.