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

LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II

K Number: K932076 · Decision Jun 29, 1993
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
319
Review Days
61

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Basic Information

Device Name
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
K Number
K932076
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.1660
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Bio-Rad
Date Received
April 29, 1993
Decision Date
June 29, 1993
Product Code
JJY
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
JJY Multi-Analyte Controls, All Kinds (Assayed)

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