Product code KWW— Clinical Chemistry

FDA has cleared 6 devices under product code KWW between 1978 and 2007, filed by 6 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.

• 20071 clearance
• 20051 clearance
• 19971 clearance
• 19871 clearance
• 19811 clearance
• 19781 clearance

• Teco Diagnostics1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Immunotech Corp.1 clearance
• Diazyme Laboratories1 clearance
• Catachem, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITCatachem, Inc.·2007-01-19
• K051714 — TOTAL BILE ACIDS ASSAY, MODEL DZ042ADiazyme Laboratories·2005-12-07
• K970120 — BILE ACIDS REAGENT SETTeco Diagnostics·1997-03-24
• K872296 — BILE ACIDS REAGENTSigma Diagnostics, Inc.·1987-08-26
• K803296 — ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KITImmunotech Corp.·1981-01-16
• K781337 — CONJUGATED BILE ACIDS RIA KITBd Becton Dickinson Vacutainer Systems Preanalytic·1978-08-11