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

FDA 510(k) Regulatory Record - Helena Laboratories Pathology ✕

3 devices

1-3 of 3

Cleared May 06, 1986

PERMACLEAR SOLUTION CAT. NO. 4950

Pathology · 14d

Cleared Feb 27, 1984

TITAN GEL SILVER STAIN SYSTEM

Pathology · 112d

Cleared Mar 26, 1982

AVES WRIGHT STAIN

Pathology · 37d