Ames Tda TM Primidone Test
FDA 510(k) K811007 · Miles Laboratories, Inc.
510(k) numberK811007
Submission
- Device name
- Ames Tda TM Primidone Test
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- April 14, 1981
- Decision date
- April 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFT – Fluorescent Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950028 | Primidone Fpia Reagent Set and CalibratorsLFT · Traditional | Sigma Diagnostics, Inc. | 03/21/1995SE |
| K904683 | Stratus Primidone Fluorometric EnzymeLFT · Traditional | Baxter Healthcare Corp | 11/28/1990SE |
| K895567 | Primidone (Fpia) KitLFT · Traditional | Tudor Laboratories, Inc. | 10/20/1989SE |
| K852318 | Cobas FP Reagen for Primidone & Primi CalibratorsLFT · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| K842196 | Stratus Primidone Florometric EnzyLFT · Traditional | American Dade | 07/11/1984SE |
| K823741 | Advance Emit-Aed Primedone AssayLFT · Traditional | Syva Co. | 01/07/1983SE |
| K822229 | Primidone Fluorescent ImmunoassayLFT · Traditional | American Diagnostic Corp. | 08/12/1982SE |
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| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Ames Tda TM Primidone Test cleared by the FDA?
Ames Tda TM Primidone Test (K811007) received a 510(k) decision of Substantially Equivalent on April 29, 1981, 15 days after the submission was received.
What is the product code of K811007?
The FDA product code is LFT – Fluorescent Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.