Atlas FDA

MICRODILUTION PANELS

FDA 510(k) clearance K862140 · decided 1986-07-16

Clearance details

K-number
K862140
Device name
MICRODILUTION PANELS
Applicant
American Micro Scan
Decision
Substantially Equivalent
Date received
1986-06-04
Decision date
1986-07-16
Days to decision
42 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan N recall (Z-1522-2015)Beckman Coulter, Inc.2015-04-26
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Nu recall (Z-1497-2012)Siemens Healthcare Diagnostics, Inc.2012-05-08
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, recall (Z-1498-2012)Siemens Healthcare Diagnostics, Inc.2012-05-08
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, recall (Z-1499-2012)Siemens Healthcare Diagnostics, Inc.2012-05-08

PMA approvals by this applicant

RecordFirmDate
MIC PANELS (N62160/S013)American Micro Scan1985-03-05
MIC PANELS (N62160/S011)American Micro Scan1984-01-30
MIC PANELS (N62160/S012)American Micro Scan1984-01-30
MIC PANELS (N62160/S010)American Micro Scan1983-10-12
MIC PANELS (N62160/S009)American Micro Scan1983-09-28
MIC PANELS (N62160/S008)American Micro Scan1983-08-10
MIC PANELS (N62160/S007)American Micro Scan1983-02-03
MIC PANELS (N62160/S006)American Micro Scan1982-11-18