Erythrocyte Test

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K832771 ↗

FDA Product Code

LKZ

Device Class

Class II

Regulation

21 CFR Part 864.7100

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Urea Nitrogen, Kinetic

  Class II

  FDA 510(k) K810087 Active Cleared 26 Feb 1981

• Uric Acid (Tptz) Colorinmetric

  Class I

  FDA 510(k) K810088 Active Cleared 28 Jan 1981

• Acetaminophen(Paracetamol

  Class II

  FDA 510(k) K832567 Active Cleared 12 Sep 1983

• Ldh-L Liquid Enzymatic, Kinetic Kit

  Class II

  FDA 510(k) K810083 Active Cleared 28 Jan 1981

• Enzymatic Alpha-Amylase Reagent Kit

  Class II

  FDA 510(k) K860245 Active Cleared 14 Mar 1986

• Albumin Reagent Kit

  Class II

  FDA 510(k) K860213 Active Cleared 11 Feb 1986

See all devices from Bio-Analytics Laboratories, Inc. →

• What is the Erythrocyte Test used for?

  The Erythrocyte Test is a medical device designed for laboratory use to measure red blood cell counts through photometric analysis in hematology applications. It provides quantitative data on erythrocyte levels for diagnostic purposes.

• How is the Erythrocyte Test supplied and is it reusable?

  The Erythrocyte Test is supplied as a single-use product, meaning it should be used for one patient procedure and then discarded. This design helps prevent cross-contamination between samples and ensures accurate results.

• What are the storage requirements for the Erythrocyte Test?

  The Erythrocyte Test requires specific storage conditions as specified by the manufacturer, Bio-Analytics Laboratories, Inc. Proper storage is essential to maintain the device's integrity and ensure accurate test results. Users should consult the manufacturer's instructions for detailed storage guidelines.

• What regulatory approvals does the Erythrocyte Test have?

  The Erythrocyte Test received FDA 510(k) clearance on October 28, 1983, with K number K832771. It is classified as a Class II medical device under product code LKZ and regulation number 864.7100. The device was reviewed by the Hematology advisory committee during the clearance process.