IC MICROASSAY— 510(k) K864312

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K864312 for IC MICROASSAY, Substantially Equivalent on 1987-01-09. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code DAK
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1986-11-03
Decision date: 1987-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAK

K031563 — BINDAZYME CLQ CIC EIA KIT2003-09-10
K032254 — IBL C1Q-CIC CIA TEST2003-08-29
K012576 — CIC-C1Q EIA2002-01-29
K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES1998-09-30
K972873 — IMMUSTRIP HAMA IGG1998-03-17

More clearances from Diamedix Corp.

K093101 — MAGO 4S2011-01-21
K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM2002-07-09
K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN2002-01-08
K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM2001-12-21
K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM2001-10-26

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