Atlas FDA

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS

FDA 510(k) clearance K860153 · decided 1986-03-04

Clearance details

K-number
K860153
Device name
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
Applicant
Oxoid U.S.A., Inc.
Decision
Substantially Equivalent
Date received
1986-01-15
Decision date
1986-03-04
Days to decision
48 days
Clearance type
Traditional
Product code
JTN
Device class
2
Regulation number
866.1620
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hampshire Rg 24 Op, GB
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

RecordFirmDate
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The fir recall (Z-1246-2014)Remel Inc2014-03-20
Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in ca recall (Z-0794-2014)Remel Inc2014-01-21
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs p recall (Z-0528-2014)Remel Inc2013-12-17
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packag recall (Z-2081-2013)Remel Inc2013-08-26
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 dis recall (Z-0808-2013)Remel Inc2013-02-12