Product code LKA— Microbiology

FDA has cleared 5 devices under product code LKA between 1983 and 1987, filed by 2 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.

• 19873 clearances
• 19832 clearances

• I.A.F. Production, Inc.3 clearances
• Acumedia Manufacturers, Inc.2 clearances

• K872686 — IAFP MUELLER HINTON AGARI.A.F. Production, Inc.·1987-08-11
• K872687 — IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENTI.A.F. Production, Inc.·1987-08-11
• K872688 — IAFP MUELLER HINTON AGAR W/5% SHEEP BLOODI.A.F. Production, Inc.·1987-08-11
• K833207 — AK AGAR 2Acumedia Manufacturers, Inc.·1983-10-27
• K833218 — YEAST BEEF AGAR-ANTIBIOTIC MED.4Acumedia Manufacturers, Inc.·1983-10-27