HEMOLYSE— 510(k) K863503

Substantially Equivalent

Reagent Laboratory, Inc.

FDA 510(k) clearance K863503 for HEMOLYSE, Substantially Equivalent on 1986-10-03. Applicant: Reagent Laboratory, Inc.. Device class: 1.

Clearance details

Applicant: Reagent Laboratory, Inc.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1986-09-09
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGK

K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II1988-11-30
K883991 — KVM HEMOGLOBIN LYSING REAGENT1988-10-12
K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT1987-10-20
K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.1987-09-09
K863114 — PIASTRINIT1986-11-06

More clearances from Reagent Laboratory, Inc.

K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L1986-10-21
K863550 — POTASSIUM HYDROXIDE 10% W/V1986-10-02
K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE1986-02-10
K842982 — FORMALIN BUFFERED1984-10-01
K842785 — STAIN, METHYLENE BLUE-EOSIN1984-09-11

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