GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN— 510(k) K852986

Name: FDA 510(k) clearance K852986
Creator: U.S. Food and Drug Administration
Published: 1985-08-19

Substantially Equivalent

Clinical Technology Corp.

FDA 510(k) clearance K852986 for GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN, Substantially Equivalent on 1985-08-19. Applicant: Clinical Technology Corp.. Device class: 2.

Clearance details

Applicant: Clinical Technology Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1985-07-15
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rocky Point, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCP

view all

K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer2024-11-22
K231465 — Q-Pad Test System2023-12-06
K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer2023-09-27
K192987 — Aina HbA1c Monitoring System 22020-03-26
K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2019-10-29

More clearances from Clinical Technology Corp.

view all

K925080 — TEK-LUBE1994-01-31
K872867 — BIOSIGN1988-07-06
K880166 — BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME20001988-02-18
K872705 — BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)1987-09-01
K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM1986-11-10

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