AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)— 510(k) K980030

Name: FDA 510(k) clearance K980030
Creator: U.S. Food and Drug Administration
Published: 1998-01-30

Substantially Equivalent

Trace America, Inc.

FDA 510(k) clearance K980030 for AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), Substantially Equivalent on 1998-01-30. Applicant: Trace America, Inc.. Device class: 2.

Clearance details

Applicant: Trace America, Inc.
Product code: Code CIT
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1998-01-05
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIT

view all

K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-2010-09-20
K080485 — ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS2008-12-04
K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE2008-03-19
K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL2007-10-03
K071211 — COBAS C 111 ANALYZER2007-07-30

More clearances from Trace America, Inc.

view all

K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR669012001-01-17
K980026 — GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)1998-03-10
K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)1998-02-02
K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA1998-01-07
K974620 — AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)1998-01-02

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