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

MICROSTATIC URINE TRANSPORT TUBE FOR C & S

K Number: K851387 · Decision May 20, 1985
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
2
Review Days
41

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Basic Information

Device Name
MICROSTATIC URINE TRANSPORT TUBE FOR C & S
K Number
K851387
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2900
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
Analytical Luminescence Laboratory, Inc.
Date Received
April 9, 1985
Decision Date
May 20, 1985
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

Similar 510(k) Clearances

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Other Clearances by Analytical Luminescence Laboratory, Inc.

K Number Device Name
K820126 RAPID BACTERIURIA SCREENING TEST