PARAMAX IRON BLANK REAGENT— 510(k) K841887

Substantially Equivalent

American Dade

FDA 510(k) clearance K841887 for PARAMAX IRON BLANK REAGENT, Substantially Equivalent on 1984-06-22. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1984-05-07
Decision date: 1984-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIY

K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR2006-08-07
K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)2006-03-08
K051115 — SENTINEL IRON LIQUID2005-08-25
K033983 — VITALAB IRON REAGENT2004-05-21
K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)2003-06-17

More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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