Atlas FDA

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS

FDA 510(k) clearance K912365 · decided 1991-08-16

Clearance details

K-number
K912365
Device name
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1991-05-29
Decision date
1991-08-16
Days to decision
79 days
Clearance type
Traditional
Product code
JXN
Device class
2
Regulation number
862.3700
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795)Lin-Zhi International, Inc.2003-01-21
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032)Abbott Laboratories2026-05-11
ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068)Abbott Laboratories2026-02-23
ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056)Abbott Laboratories2026-02-12
ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067)Abbott Laboratories2026-02-12
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031)Abbott Laboratories2026-02-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
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