Atlas FDA

TRF

FDA 510(k) clearance K983167 · decided 1998-11-04

Clearance details

K-number
K983167
Device name
TRF
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-09-10
Decision date
1998-11-04
Days to decision
55 days
Clearance type
Traditional
Product code
DDG
Device class
2
Regulation number
866.5880
Medical specialty
Immunology
Advisory committee
Immunology
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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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
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30