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

ACETAMIDE AGAR

K Number: K830020 · Decision Feb 7, 1983
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
67
Review Days
34

Basic Information

Device Name
ACETAMIDE AGAR
K Number
K830020
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2320
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
Date Received
January 4, 1983
Decision Date
February 7, 1983
Product Code
JSH
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
JSH Culture Media, Non-Selective And Differential

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K864014 LOMBARD DOWELL AGAR BASE
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K863820 DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
K863289 CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
K862425 MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
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