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

MICROFLAME PHOTOMETER

K Number: K792087 · Decision Nov 13, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
21
Applicant Total
16
Review Days
27

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Basic Information

Device Name
MICROFLAME PHOTOMETER
K Number
K792087
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2540
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Gilford Instrument Laboratories, Inc.
Date Received
October 17, 1979
Decision Date
November 13, 1979
Product Code
JJO
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
JJO Flame Emission Photometer For Clinical Use

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K Number Device Name
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K802609 CHEMISTRY ANALYZER IMPACT 400
K801889 MODEL 203S CLINICAL CHEMISTRY ANALYZER
K800085 SYSTEM 203 CHEMISTRY ANALYZER
K792361 SYSTEM 103 CHEMISTRY ANALYZER
K791968 EIA (ELISA) READER
K790072 ANALYZER, IMPACT 200
K790073 ANALYZER, IMPACT 100
K781269 ELISA SYSTME
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