Product code CEX— Clinical Chemistry

FDA has cleared 8 devices under product code CEX between 1977 and 1987, filed by 8 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.

• 19871 clearance
• 19851 clearance
• 19841 clearance
• 19822 clearances
• 19801 clearance
• 19781 clearance
• 19771 clearance

• Worthington Biochemical Corp.1 clearance
• Union Carbide Corp.1 clearance
• Seragen Diagnostics, Inc.1 clearance
• Helena Laboratories1 clearance
• Harleco Diagnostics1 clearance
• Data Medical Associates, Inc.1 clearance
• Bio-Reagents & Diagnostics, Inc.1 clearance
• Berwick Medical Products, Inc.1 clearance

• K872891 — LACTATE DEHYDROGENASE ISOENZYME 1Data Medical Associates, Inc.·1987-09-16
• K851521 — LD-1(IMMUNO) SEPARATION SETSeragen Diagnostics, Inc.·1985-05-10
• K842018 — ISO-SEP SYSTEMBerwick Medical Products, Inc.·1984-09-28
• K821983 — TITAN GEL LDH ISOENZYME KITHelena Laboratories·1982-12-22
• K821879 — ULTRACHEM T.P.Harleco Diagnostics·1982-07-14
• K800129 — CENTRIFICHEM CREATININEUnion Carbide Corp.·1980-02-13
• K772356 — LDH ISOENZYME COLUMN REAGENT SETWorthington Biochemical Corp.·1978-01-24
• K771894 — LDH ISOENZYME CONTROLBio-Reagents & Diagnostics, Inc.·1977-12-22