Product code LHK— Microbiology

FDA has cleared 4 devices under product code LHK between 1981 and 1989, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19891 clearance
• 19821 clearance
• 19812 clearances

• Ramco Laboratories, Inc.1 clearance
• Nolan Biological Laboratories, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• American Scientific Products1 clearance

• K893753 — DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1989-10-16
• K823016 — CANDIDA DETECTION SYSTEMRamco Laboratories, Inc.·1982-12-28
• K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSISNolan Biological Laboratories, Inc.·1981-10-23
• K812186 — CANDIDA IMMUNODIFFUSION SYSTEMAmerican Scientific Products·1981-08-25