Trichrome Stain LG Solution
FDA 510(k) K833167 · Sigma Chemical Co.
510(k) numberK833167
Submission
- Device name
- Trichrome Stain LG Solution
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- September 16, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K051409 | SlivasureLED · Traditional | Scandinavian Formulas, Inc. | 08/08/2005SE |
| 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 |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Trichrome Stain LG Solution cleared by the FDA?
Trichrome Stain LG Solution (K833167) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 45 days after the submission was received.
What is the product code of K833167?
The FDA product code is LED – Stains, Chemical Solution, a Class I (low risk) device regulated under 21 CFR 864.1850.