Analytes Albumin, Total Bilirubin, AST, ALT GEN2 S

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K851308 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Technicon Instruments Corp. →

• What is the ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S device used for?

  This device is a Bromcresol Green Dye-binding assay designed to measure albumin, total bilirubin, AST, and ALT as part of liver function testing in clinical laboratory settings for in vitro diagnostic use.

• Who manufactures the ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S device and when was it cleared?

  The device was manufactured by Technicon Instruments Corp. and received FDA 510(k) clearance (K851308) on April 17, 1985, as a substantially equivalent device under product code CIX and regulation number 862.1035.

• What type of assay is the ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S and what product code does it fall under?

  It is a Bromcresol Green Dye-binding assay for albumin, classified under Clinical Chemistry with product code CIX, and is intended for the in vitro diagnostic measurement of albumin, total bilirubin, AST, and ALT.