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

CHROMATOGRAPHY CLINICAL USE 75JQR

K Number: K914841 · Decision Dec 10, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
24
Applicant Total
30
Review Days
46

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Basic Information

Device Name
CHROMATOGRAPHY CLINICAL USE 75JQR
K Number
K914841
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2260
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Millipore Corp.
Date Received
October 25, 1991
Decision Date
December 10, 1991
Product Code
KIE
Advisory Committee
Clinical Chemistry
Review Advisory Committee
TX
Third Party
N

Classifications

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

Product Code Device Name
KIE Apparatus, High Pressure Liquid Chromatography

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