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

MR 600 MICROPLATE READER

K Number: K823512 · Decision Mar 1, 1983
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
1
Review Days
92

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Basic Information

Device Name
MR 600 MICROPLATE READER
K Number
K823512
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2300
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Laboratory and Medical Products Group
Date Received
November 29, 1982
Decision Date
March 1, 1983
Product Code
JJQ
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
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

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