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

MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG

K Number: K801772 · Decision Aug 20, 1980
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
14
Applicant Total
7
Review Days
23

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Basic Information

Device Name
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG
K Number
K801772
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2310
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Radiation Technology, Inc.
Date Received
July 28, 1980
Decision Date
August 20, 1980
Product Code
JJH
Advisory Committee
Clinical Chemistry
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
JJH Clinical Sample Concentrator

Similar 510(k) Clearances

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Other Clearances by Radiation Technology, Inc.

K Number Device Name
K910648 THERAPY CHAIR SYSTEM
K802892 CULTURE MEDIA FOR IN VITRO DIAG. USE
K801943 BRAIN HEART INFUSION MICROBIOLOGICAL
K801817 MICROBIOLOGY CULTURE MEDIA, C.L.E.D.
K801901 MUELLER HINTON AGAR
K801847 TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA