Reticulocyte Stain
FDA 510(k) K875310 · Sigma Diagnostics, Inc.
510(k) numberK875310
Submission
- Device name
- Reticulocyte Stain
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- December 29, 1987
- Decision date
- February 9, 1988
- 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 |
|---|---|---|---|
| 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 |
| 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 Reticulocyte Stain cleared by the FDA?
Reticulocyte Stain (K875310) received a 510(k) decision of Substantially Equivalent on February 9, 1988, 42 days after the submission was received.
What is the product code of K875310?
The FDA product code is KFC – Methylene Blue, Tissue Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.