FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CLINICAL CHEMISTRY ANALYTICAL SYSTEM

K Number: K851933 · Decision Jun 10, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
7
Review Days
39

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Basic Information

Device Name
CLINICAL CHEMISTRY ANALYTICAL SYSTEM
K Number
K851933
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2170
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Allied Instrumentation Laboratory
Date Received
May 2, 1985
Decision Date
June 10, 1985
Product Code
JJF
Advisory Committee
Clinical Chemistry
Review Advisory Committee
CH
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JJF Analyzer, Chemistry, Micro, For Clinical Use

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K Number Device Name
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K860286 IL TEST PHENYTOIN
K853858 IL TEST THEOPHYLLINE ASSAY
K852676 IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS
K850748 I-L TEST, DIRECT BILIRUBIN SET