Phenytoin Reagent Test Kit
FDA 510(k) K802038 · Beckman Instruments, Inc.
510(k) numberK802038
Submission
- Device name
- Phenytoin Reagent Test Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- August 25, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DID – Bacillus Subtilis Microbiology Assay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820773 | Emit-St Urine Cocaine Metabolite AssayDID · Traditional | Syva Co. | 04/08/1982SE |
| K780950 | Bio-Monitor TobramycinDID · Traditional | Monitor Science Corp. | 08/14/1978SE |
| K780182 | Tobramycin 125I Ria KitDID · Traditional | New England Nuclear | 02/13/1978SE |
| K780048 | Aminoglycoside Test SystemDID · Traditional | Nichols Institute Diagnostics | 01/20/1978SE |
More from Nichols Institute Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Phenytoin Reagent Test Kit cleared by the FDA?
Phenytoin Reagent Test Kit (K802038) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 59 days after the submission was received.
What is the product code of K802038?
The FDA product code is DID – Bacillus Subtilis Microbiology Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.