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

NAT - NUCLEIC ACID TRANSPORT

K Number: K003761 · Decision May 31, 2001
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
10
Review Days
176

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Basic Information

Device Name
NAT - NUCLEIC ACID TRANSPORT
K Number
K003761
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2900
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Medical Packaging Corp.
Date Received
December 6, 2000
Decision Date
May 31, 2001
Product Code
LIO
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
LIO Device, Specimen Collection

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K964637 CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
K936078 CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
K932337 CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
K915454 CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K881105 CULTURE COLLECTION DEVICE
K870398 PAP-PAK CYTOBRUSH KIT
K864323 CYTOLOGY BRUSHES