Atlas FDA

REVISED LABELING FOR OPIATES

FDA 510(k) clearance K874485 · decided 1987-11-23

Clearance details

K-number
K874485
Device name
REVISED LABELING FOR OPIATES
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1987-10-30
Decision date
1987-11-23
Days to decision
24 days
Clearance type
Traditional
Product code
DJG
Device class
2
Regulation number
862.3650
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 recall (Z-1229-04)Abbott Health Products, Inc.2004-07-28

PMA approvals by this applicant

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ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
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