MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD— 510(k) K920336

Name: FDA 510(k) clearance K920336
Creator: U.S. Food and Drug Administration
Published: 1992-03-04

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K920336 for MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD, Substantially Equivalent on 1992-03-04. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CIT
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1992-01-24
Decision date: 1992-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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 Heraeus Kulzer, Inc.

view all

K091494 — FLEXITIME FLOW2009-07-31
K063062 — HKBOND 20062006-12-01
K060994 — MONDIAL2006-05-22
K052543 — HERACERAM ZIRKONIA2005-10-25
K043504 — PALAIMPACT2005-01-28

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