Product code LHT— Microbiology

FDA has cleared 13 devices under product code LHT between 1981 and 1987, filed by 7 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.

• 19871 clearance
• 19861 clearance
• 19823 clearances
• 19818 clearances

• Dutchland Laboratories, Inc.7 clearances
• Scott Laboratories, Inc.1 clearance
• Oxoid U.S.A., Inc.1 clearance
• Meridian Diagnostics, Inc.1 clearance
• Diagnostica, Inc.1 clearance
• Carr-Scarborough Microbiologicals, Inc.1 clearance
• American Scientific Products1 clearance

• K874303 — STAPHYLASE TESTOxoid U.S.A., Inc.·1987-11-06
• K863025 — SERO-STAT R II STAPHYLOCOCCUS TESTScott Laboratories, Inc.·1986-09-15
• K820531 — ENDO-STAPH TEICHOIC ACID ANTIBODY KITMeridian Diagnostics, Inc.·1982-04-14
• K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KITAmerican Scientific Products·1982-04-14
• K820347 — ACCU-STAPHCarr-Scarborough Microbiologicals, Inc.·1982-03-04
• K812434 — DIAGNOSTIC KITS & KIT COMPONENTSDiagnostica, Inc.·1981-09-23
• K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)Dutchland Laboratories, Inc.·1981-09-09
• K812368 — RAT BLOOD IN ALSEVER'S, CITRATEDDutchland Laboratories, Inc.·1981-09-09
• K812372 — GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEFDutchland Laboratories, Inc.·1981-09-09
• K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBRDutchland Laboratories, Inc.·1981-09-09
• K812374 — ADULT CHICKEN BLOOD IN ALSEVER'S, C., D.Dutchland Laboratories, Inc.·1981-09-09
• K812375 — BABY CHICK BLOOD IN ALSEVER'SDutchland Laboratories, Inc.·1981-09-09
• K812376 — SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBRDutchland Laboratories, Inc.·1981-09-09