Medical Device Manufacturer · US , Mchenry , IL

Harleco - FDA 510(k) Cleared Devices

116 submissions · 116 cleared · Since 1976

116

Total

116

Cleared

0

Denied

FDA 510(k) Regulatory Record - Harleco Hematology ✕

7 devices

1-7 of 7

Cleared Jun 22, 1978

SYSING AND HEMOGLOBIN REAGENT

Hematology · 34d

Cleared Jun 14, 1978

ISOTONIC BUFFERED SALINE

Hematology · 26d

Cleared Aug 22, 1977

HISTOCHEMICAL FERRIC IRON SET

Hematology · 14d

Cleared Sep 03, 1976

STAIN SET, HISTOCHEMICAL AFB

Hematology · 14d

Cleared Jul 20, 1976

DSP - STAIN PACK

Hematology · 36d

Cleared Jul 20, 1976

HISTOCHEMICAL PAS REACTION SET

Hematology · 36d

Cleared Jul 20, 1976

SALINE, ISOTONIC BUFFERED, AZIDE-FREE

Hematology · 22d