Slivasure
FDA 510(k) K051409 · Scandinavian Formulas, Inc.
510(k) numberK051409
Submission
- Device name
- Slivasure
- Applicant
- Scandinavian Formulas, Inc.
Sellersville, PA, US - Received
- May 31, 2005
- Decision date
- August 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LED – Stains, Chemical Solution
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code LED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023046 | SST Saliva Supporting TabletsLED · Traditional | Sinclair Pharmaceuticals, Ltd. | 12/02/2002SE |
| K860795 | Spottest Calcofluor White ReagentLED · Traditional | Difco Laboratories, Inc. | 03/12/1986SE |
| K860321 | LysocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860320 | GranulocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860319 | MegacolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860317 | NeutrocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860316 | PanoptikonLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K854176 | Polychrome IV StainLED · Traditional | Devetec, Inc. | 10/31/1985SE |
| K851481 | Spottest Iodine Solution Dobell & O'ConnorLED · Traditional | Difco Laboratories, Inc. | 04/29/1985SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | E K Ind., Inc. | 09/11/1984SE |
Questions and answers
When was Slivasure cleared by the FDA?
Slivasure (K051409) received a 510(k) decision of Substantially Equivalent on August 8, 2005, 69 days after the submission was received.
What is the product code of K051409?
The FDA product code is LED – Stains, Chemical Solution, a Class I (low risk) device regulated under 21 CFR 864.1850.