Product code GHD— Hematology

FDA has cleared 4 devices under product code GHD between 1981 and 1990, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19902 clearances
• 19891 clearance
• 19811 clearance

• Sigma Chemical Co.3 clearances
• Biodynamics Corp.1 clearance

• K904022 — NITRO BLUE TETRAZOLIUM REDUCTIONSigma Chemical Co.·1990-12-18
• K903995 — NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITSigma Chemical Co.·1990-12-13
• K896092 — ALKALINE PHOSPHATASE, LEUKOCYTE, KITSigma Chemical Co.·1989-11-09
• K811189 — CHEMSTRIP LBiodynamics Corp.·1981-07-27