Medical Device Manufacturer · US , Mchenry , IL

Helena Laboratories - FDA 510(k) Cleared Devices

280 submissions · 280 cleared · Since 1978

280

Total

280

Cleared

0

Denied

280 devices

276-280 of 280

Cleared Apr 23, 1979

QUIK COLUMN METHODOLOGY

Hematology · 27d

Cleared Jan 26, 1979

G-HB QUIK COLUMN CONTROL

Hematology · 21d

Cleared Jan 17, 1979

Chemistry · 42d

Cleared Jun 02, 1978

HBF-QUIPLATE METHODOLOGY

Hematology · 29d

Cleared Mar 28, 1978

HDL CHOLESTEROL METHOD

Chemistry · 43d

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