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

CAMPYLOBACTER THIOGLYCOLLATE MED W/5

K Number: K820060 · Decision Jan 28, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
632
Review Days
17

Basic Information

Device Name
CAMPYLOBACTER THIOGLYCOLLATE MED W/5
K Number
K820060
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2360
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Received
January 11, 1982
Decision Date
January 28, 1982
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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