NEPHROLYTE— 510(k) K831502

Substantially Equivalent

Flaitron Laboratories, Inc.

FDA 510(k) clearance K831502 for NEPHROLYTE, Substantially Equivalent on 1983-07-18. Applicant: Flaitron Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Flaitron Laboratories, Inc.
Product code: Code KFC
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1983-05-11
Decision date: 1983-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KFC

K875310 — RETICULOCYTE STAIN1988-02-09
K843919 — SPOTTEST LOEFFLER METHYLENE BLUE STAIN1984-10-30
K842785 — STAIN, METHYLENE BLUE-EOSIN1984-09-11
K842926 — METHYLENE BLUE STAIN, LOEFFLER1984-09-11
K842743 — NEW METHYLENE BLUE N1984-08-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.