LIQUID AST (SGOT)REAGENT SET— 510(k) K941132

Clearance details

Applicant

Pointe Scientific, Inc.,

Product code

Code CIT

Device class

Class 2

Regulation

21 CFR 862.1100

Advisory panel

Clinical Chemistry

Date received

1994-03-09

Decision date

1994-05-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lincoln Park, MI, US

• 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

• K070757 — MICROPROTEIN REAGENT SET2007-12-04
• K062118 — POINTE 3602007-07-13
• K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT2007-04-30
• K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
• K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

• Z-2116-2017 — Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.Class III·Terminated·Medtest Holdings, Inc.·20120215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K941132.