DIRECT IRON REAGENT SET— 510(k) K834396

Name: FDA 510(k) clearance K834396
Creator: U.S. Food and Drug Administration
Published: 1984-02-21

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K834396 for DIRECT IRON REAGENT SET, Substantially Equivalent on 1984-02-21. Applicant: Seragen Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code CFM
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1983-12-14
Decision date: 1984-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFM

view all

K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR1999-01-15
K981581 — IRON1998-06-08
K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER1993-09-08
K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A291991-10-09
K912912 — SYNERMED SERUM IRON-600 REAGENT KIT1991-07-30

More clearances from Seragen Diagnostics, Inc.

view all

K872148 — VIVID CHLAMYDIA(TM)1987-08-19
K851663 — QUICK-COUNT HEMATOLOGY CONTROLS1985-07-23
K852260 — QUICK-CHEM CALIBRATION SET1985-07-22
K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN)1985-06-25
K851521 — LD-1(IMMUNO) SEPARATION SET1985-05-10

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