Nephrolyte
FDA 510(k) K831502 · Flaitron Laboratories, Inc.
510(k) numberK831502
Submission
- Device name
- Nephrolyte
- Applicant
- Flaitron Laboratories, Inc.
Mchenry, IL, US - Received
- May 11, 1983
- Decision date
- July 18, 1983
- 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 |
| 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 |
| K770792 | Tube, Stain, Reticulocyte, LarcKFC · Traditional | Corning Medical & Scientific | 07/05/1977SE |
Questions and answers
When was Nephrolyte cleared by the FDA?
Nephrolyte (K831502) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 68 days after the submission was received.
What is the product code of K831502?
The FDA product code is KFC – Methylene Blue, Tissue Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.