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

FEKAL CHECK PARASITOLOGY CONTROL SLIDE

K Number: K862914 · Decision Sep 16, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
11
Applicant Total
6
Review Days
46

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Basic Information

Device Name
FEKAL CHECK PARASITOLOGY CONTROL SLIDE
K Number
K862914
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2480
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
Trend Scientific, Inc.
Date Received
August 1, 1986
Decision Date
September 16, 1986
Product Code
JTR
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
JTR Kit, Quality Control For Culture Media

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Other Clearances by Trend Scientific, Inc.

K Number Device Name
K954996 TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
K955755 TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
K952467 TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
K953284 TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
K830769 FEKAL CON-TRATE SYSTEM