SYSING AND HEMOGLOBIN REAGENT— 510(k) K780829

Substantially Equivalent

Harleco

FDA 510(k) clearance K780829 for SYSING AND HEMOGLOBIN REAGENT, Substantially Equivalent on 1978-06-22. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1978-05-19
Decision date: 1978-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKR

K201217 — HemoCue Hb 301 System2020-08-04
K200909 — Hemo Control (optional Add Pack Hemo Control DM)2020-06-12
K181751 — HemoCue Hb 801 System2019-02-01
K182298 — hemochroma PLUS System2018-11-16
K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes2018-04-06

More clearances from Harleco

K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056)1982-02-12
K813427 — ULTRACHEM GLUC-DH1981-12-31
K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10

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