Stain, Methylene Blue-Eosin
FDA 510(k) K842785 · Reagent Laboratory, Inc.
510(k) numberK842785
Submission
- Device name
- Stain, Methylene Blue-Eosin
- Applicant
- Reagent Laboratory, Inc.
Mchenry, IL, US - Received
- July 2, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KFC – Methylene Blue, Tissue Stain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code KFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K875310 | Reticulocyte StainKFC · Traditional | Sigma Diagnostics, Inc. | 02/09/1988SE |
| K843919 | Spottest Loeffler Methylene Blue StainKFC · Traditional | Difco Laboratories, Inc. | 10/30/1984SE |
| K842926 | Methylene Blue Stain, LoefflerKFC · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842743 | New Methylene Blue NKFC · Traditional | E K Ind., Inc. | 08/12/1984SE |
| K831502 | NephrolyteKFC · Traditional | Flaitron Laboratories, Inc. | 07/18/1983SE |
| K770792 | Tube, Stain, Reticulocyte, LarcKFC · Traditional | Corning Medical & Scientific | 07/05/1977SE |
More from Corning Medical & Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K863502 | Solution B- Na 50MEQ/L, K 40 Meq/LJIX · Traditional | 10/21/1986SE |
| K863503 | HemolyseGGK · Traditional | 10/03/1986SE |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | 10/02/1986SE |
| K860143 | Urine Diluent-For Use with Ion Selective ElectrodeJJP · Traditional | 02/10/1986SE |
| K842982 | Formalin BufferedIFP · Traditional | 10/01/1984SE |
| K843050 | Gram StainJTS · Traditional | 09/11/1984SE |
| K841847 | Lithium ReagentJJO · Traditional | 08/17/1984SE |
| K843051 | Wrights Stain Solution · Traditional | 08/03/1984SESP |
| K841800 | Lysing & Hemoglobin ReagentGGK · Traditional | 05/31/1984SE |
| K841799 | Cyanomethemoglobin ReagentGIF · Traditional | 05/31/1984SE |
Questions and answers
When was Stain, Methylene Blue-Eosin cleared by the FDA?
Stain, Methylene Blue-Eosin (K842785) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 71 days after the submission was received.
What is the product code of K842785?
The FDA product code is KFC – Methylene Blue, Tissue Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.