Medical Device Manufacturer · US , Mchenry , IL

E K Ind., Inc. - FDA 510(k) Cleared Devices

50 submissions · 49 cleared · Since 1984

50

Total

49

Cleared

0

Denied

FDA 510(k) Regulatory Record - E K Ind., Inc. Hematology ✕

11 devices

1-11 of 11

Cleared Sep 21, 1984

DRABKIN REAGENT

Hematology · 58d

Cleared Sep 14, 1984

ACETIC ACID 1% V/V

Hematology · 51d

Cleared Sep 12, 1984

ACETIC ACID, 5% V/V

Hematology · 49d

Cleared Sep 12, 1984

ACETIC ACID, 3% V/V

Hematology · 49d

Cleared Sep 12, 1984

ACETIC ACID 2% V/V

Hematology · 49d

Cleared Sep 07, 1984

REES & ECKER DILUTION FLUID

Hematology · 44d

Cleared Sep 07, 1984

HAYEM DILUTING FLUID

Hematology · 44d

Cleared Aug 15, 1984

Hematology · 33d

Cleared Aug 12, 1984

NEW METHYLENE BLUE N

Hematology · 30d

Cleared Aug 03, 1984

SALINE, 0.85%W/PRESERVATIVE

Hematology · 21d

Cleared Aug 03, 1984

DECOLORIZING FLUID

Hematology · 21d