Product code JWL— Microbiology

FDA has cleared 4 devices under product code JWL between 1980 and 1983, 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.

• 19831 clearance
• 19803 clearances

• Parasitic Disease Consultants1 clearance
• Miles Laboratories, Inc.1 clearance
• Immuno-Diagnostic Products, Inc.1 clearance
• Bioware Products1 clearance

• K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILISParasitic Disease Consultants·1983-07-26
• K801959 — FTA-ABS TESTImmuno-Diagnostic Products, Inc.·1980-10-23
• K802276 — FTA-ABS BIOPAKBioware Products·1980-10-23
• K801928 — LAB-TEK FTA-ABS KITMiles Laboratories, Inc.·1980-08-20