Primidone Fpia Reagent Set and Calibrators
FDA 510(k) K950028 · Sigma Diagnostics, Inc.
510(k) numberK950028
Submission
- Device name
- Primidone Fpia Reagent Set and Calibrators
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- January 4, 1995
- Decision date
- March 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K811007 | Ames Tda TM Primidone TestLFT · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional | 08/30/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Primidone Fpia Reagent Set and Calibrators cleared by the FDA?
Primidone Fpia Reagent Set and Calibrators (K950028) received a 510(k) decision of Substantially Equivalent on March 21, 1995, 76 days after the submission was received.
What is the product code of K950028?
The FDA product code is LFT – Fluorescent Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.