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

ELECTROPHORESIS ACCESSORY MO. 3526

K Number: K761248 · Decision Dec 21, 1976
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
33
Applicant Total
16
Review Days
8

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Basic Information

Device Name
ELECTROPHORESIS ACCESSORY MO. 3526
K Number
K761248
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2485
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Gilford Instrument Laboratories, Inc.
Date Received
December 13, 1976
Decision Date
December 21, 1976
Product Code
JJN
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
JJN Apparatus, Electrophoresis, For Clinical Use

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K800085 SYSTEM 203 CHEMISTRY ANALYZER
K792361 SYSTEM 103 CHEMISTRY ANALYZER
K792087 MICROFLAME PHOTOMETER
K791968 EIA (ELISA) READER
K790072 ANALYZER, IMPACT 200
K790073 ANALYZER, IMPACT 100
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