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

FLAME PHOTOMETER T281-T282-T283

K Number: K832886 · Decision Dec 8, 1983
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
21
Applicant Total
10
Review Days
104

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Basic Information

Device Name
FLAME PHOTOMETER T281-T282-T283
K Number
K832886
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2540
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Texas Intl. Laboratories, Inc.
Date Received
August 26, 1983
Decision Date
December 8, 1983
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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K900685 CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
K884006 HEMAT 12
K883177 H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
K853722 PLT-4 PLATELET ANALYZER
K832890 HEMACOMP 7 OR HEMATIL 7
K831649 THERMOMIXER S213-PHOTOANALYZER S263