MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYDAS(TM)-MB2/MYDAS(TM)-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMBRITROL CK-MB CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MARRIA-HPRL RIA KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LABELLING CHANGES TO IMPRES-MB-X

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SHARIA-LH RIA KIT FOR QUANTITATION HORMO

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMUNOCCULT-LXI

FDA 510(k)

FDA Class 2 ·Hematology

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

125 I-T4 RIA TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMACK-MB(TM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMUNOCCULT EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

CHECK-MM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMACK-MB TEST PROCEDURE (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

125I QUICK-MB TEST KIT FOR QUANTITATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAMBI-CK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.

FDA 510(k)

FDA Class 2 ·Hematology

MICROMI-CK(TM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANDRIA-FSH RIA TEST KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ISOFOR-MM (TM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry