MEASLES IGG MICROASSAY— 510(k) K903961

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K903961 for MEASLES IGG MICROASSAY, Substantially Equivalent on 1990-12-28. Applicant: Diamedix Corp.. Device class: 1.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LJB
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1990-08-28
Decision date: 1990-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJB

K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEM1998-01-28
K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG1997-07-22
K922330 — BARTELS RUBEOLA IGG EIA1992-09-02
K922335 — BARTELS RUBEOLA IGM EIA1992-09-02
K910290 — VIRATEST-DIA(TM) MEASLES (RUBEOLA)1992-03-18

More clearances from Diamedix Corp.

K093101 — MAGO 4S2011-01-21
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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.