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

ANAEROBE RAPID CHROMOGENIC ID PANEL

K Number: K862332 · Decision Aug 27, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
17
Applicant Total
24
Review Days
69

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Basic Information

Device Name
ANAEROBE RAPID CHROMOGENIC ID PANEL
K Number
K862332
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2660
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
American Micro Scan
Date Received
June 19, 1986
Decision Date
August 27, 1986
Product Code
JSP
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
JSP Kit, Anaerobic Identification

Similar 510(k) Clearances

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Other Clearances by American Micro Scan

K Number Device Name
K864662 CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K870029 IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
K863776 MICRODILUTION MIC PANELS
K864674 MICRODILUTION IDENTIFICATION PANELS
K864389 CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K863038 GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K862642 GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862140 MICRODILUTION PANELS
K861584 GRAM NEGATIVE COMBO PANEL TYPE 3
K860575 YEAST IDENTIFICATION PANEL
Search all 24 clearances from American Micro Scan →