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

BRUCELLA AGAR

K Number: K833886 · Decision Dec 12, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
93
Review Days
33

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Basic Information

Device Name
BRUCELLA AGAR
K Number
K833886
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2360
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
Oxoid U.S.A., Inc.
Date Received
November 9, 1983
Decision Date
December 12, 1983
Product Code
JSJ
Advisory Committee
Microbiology
Review Advisory Committee
MI
Third Party
N

Classifications

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

Product Code Device Name
JSJ Culture Media, Selective And Non-Differential

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K874303 STAPHYLASE TEST
K872956 SORBITOL MACCONKEY AGAR NO. 3 CM 813
K872135 MCBRIDE MEDIUM CM 819
K870945 RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K862946 OXOID SIGNAL BLOOD CULTURE SYSTEM
K855236 DIAGNOSTIC REAGENT TST-RPLA
K855234 DIAGNOSTIC REAGENT VET-RPLA
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