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

CIN AGAR

K Number: K832588 · Decision Sep 12, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
8
Review Days
41

Basic Information

Device Name
CIN AGAR
K Number
K832588
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2360
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
LABORATORY PRODUCTS, INC.
Date Received
August 2, 1983
Decision Date
September 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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K Number Device Name
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K803050 SPRAY, SYNTHETIC SMEAR
K800180 VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
K792482 CHEMISTRY ANALYZER REAGENTS
K792481 CULTURE PLATES & TUBED MEDIA
K792483 STAINS, COUNTERSTAINS & GEN. PURPOSE