Product code LCA— Clinical Toxicology

FDA has cleared 5 devices under product code LCA between 1980 and 1988, filed by 5 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.

• 19881 clearance
• 19841 clearance
• 19822 clearances
• 19801 clearance

• Ria Diagnostics1 clearance
• Photec Diagnostics, Inc.1 clearance
• Medical & Scientific Designs, Inc.1 clearance
• Kallestad Laboratories, Inc.1 clearance
• Bioclinical Corp.1 clearance

• K880291 — THEOPHYLLINE TEST KIT REF. #A874799Photec Diagnostics, Inc.·1988-03-24
• K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAYMedical & Scientific Designs, Inc.·1984-01-24
• K821862 — QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.Kallestad Laboratories, Inc.·1982-07-06
• K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.Bioclinical Corp.·1982-05-28
• K792062 — THEOPHYLLINE RIASSAYRia Diagnostics·1980-02-25