Product code CIS— Clinical Chemistry

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

Classification name: Hydrazone Colorimetry, Ast/Sgot
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Total cleared: 5
First cleared: 1979-12-06
Most recent: 2003-09-05

Market context for product code CIS

FDA has cleared 5 devices under product code CIS between 1979 and 2003, 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.

Clearances per year

20031 clearance
19901 clearance
19851 clearance
19811 clearance
19791 clearance

Top applicants under product code CIS

Volu Sol Medical Industries1 clearance
Roche Diagnostic Systems, Inc.1 clearance
Instrumentation Laboratory CO1 clearance
Clinical Data, Inc.1 clearance
Cholestech Corp.1 clearance

Recent clearances under product code CIS

K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)Cholestech Corp.·2003-09-05
K896238 — COBAS READY AST REAGENTRoche Diagnostic Systems, Inc.·1990-02-16
K854187 — IN-VITRO TEST DETERMINATION OF SGOT (AST)Clinical Data, Inc.·1985-11-25
K812872 — OPTIONAL TOTAL CA-MODULE FOR IL 504/508Instrumentation Laboratory CO·1981-10-26
K792410 — ELVI SGOT & SGPT TRANSAMINASEVolu Sol Medical Industries·1979-12-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.