Hemagen Diagnostics, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 17, 1992

HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)

K915272 · LJM

Immunology · 113d

Cleared Feb 12, 1992

HEMAGEN ENA SCL-70 KIT (EIA METHOD)

K915282 · LLL

Immunology · 79d

Cleared Dec 20, 1991

HEMAGEN ENA SCREENING KIT (EIA METHOD)

K915058 · LLL

Immunology · 42d

Cleared Dec 20, 1991

HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)

K915234 · LLL

Immunology · 28d

Cleared Mar 06, 1991

HEMAGEN ENA SCREENING KIT

K910232 · LLL

Immunology · 47d

Cleared May 18, 1990

HEMAGEN ENA [JO-I] KIT

K902139 · DHN

Immunology · 9d

Cleared Feb 23, 1990

SERATEST ENA [SSA] KIT

K900617 · LLL

Immunology · 15d

Cleared Aug 02, 1989

SERATEST ENA [SCL-70] KIT

K894411 · LKJ

Immunology · 16d

Cleared Aug 19, 1986

SERATEST ENA [SS-B] KIT

K862700 · LLL

Immunology · 35d

Cleared Apr 22, 1986

SERATEST RF (HEMAGGLUTINATION) KIT

K855221 · DHR

Immunology · 113d