Spottest Loeffler Methylene Blue Stain
FDA 510(k) K843919 · Difco Laboratories, Inc.
510(k) numberK843919
Submission
- Device name
- Spottest Loeffler Methylene Blue Stain
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- October 5, 1984
- Decision date
- October 30, 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 |
| K842926 | Methylene Blue Stain, LoefflerKFC · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842785 | Stain, Methylene Blue-EosinKFC · Traditional | Reagent Laboratory, 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 |
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Questions and answers
When was Spottest Loeffler Methylene Blue Stain cleared by the FDA?
Spottest Loeffler Methylene Blue Stain (K843919) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 25 days after the submission was received.
What is the product code of K843919?
The FDA product code is KFC – Methylene Blue, Tissue Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.