Product code LED— Hematology

FDA has cleared 16 devices under product code LED between 1981 and 2005, filed by 9 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.

• 20051 clearance
• 20021 clearance
• 19866 clearances
• 19852 clearances
• 19843 clearances
• 19832 clearances
• 19811 clearance

• Cytocolor, Inc.5 clearances
• Sigma Chemical Co.2 clearances
• E K Ind., Inc.2 clearances
• Difco Laboratories, Inc.2 clearances
• Sinclair Pharmaceuticals, Ltd.1 clearance
• Scandinavian Formulas, Inc.1 clearance
• Preventive Diagnostics Corp.1 clearance
• Devetec, Inc.1 clearance
• American Scientific Products1 clearance

• K051409 — SLIVASUREScandinavian Formulas, Inc.·2005-08-08
• K023046 — SST SALIVA SUPPORTING TABLETSSinclair Pharmaceuticals, Ltd.·2002-12-02
• K860795 — SPOTTEST CALCOFLUOR WHITE REAGENTDifco Laboratories, Inc.·1986-03-12
• K860316 — PANOPTIKONCytocolor, Inc.·1986-02-20
• K860317 — NEUTROCOLORCytocolor, Inc.·1986-02-20
• K860319 — MEGACOLORCytocolor, Inc.·1986-02-20
• K860320 — GRANULOCOLORCytocolor, Inc.·1986-02-20
• K860321 — LYSOCOLORCytocolor, Inc.·1986-02-20
• K854176 — POLYCHROME IV STAINDevetec, Inc.·1985-10-31
• K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNORDifco Laboratories, Inc.·1985-04-29
• K842930 — GOMORI'S TRICHROME STAINE K Ind., Inc.·1984-09-11
• K842727 — SUPERMOUNTE K Ind., Inc.·1984-08-03
• K840087 — PRESERV GOMORI TRICHROME STAIN 125/500Preventive Diagnostics Corp.·1984-02-10
• K833167 — TRICHROME STAIN LG SOLUTIONSigma Chemical Co.·1983-10-31
• K833388 — IRON STAIN PROCEDURE HT20Sigma Chemical Co.·1983-10-31
• K812192 — LACTO-PHENOL ANILINE BLUE MOUNTING FLUIDAmerican Scientific Products·1981-08-31