Atlas FDA

LCX CHLAMYDIA TRACHOMATIS ASSAY

FDA 510(k) clearance K934622 · decided 1995-12-08

Clearance details

K-number
K934622
Device name
LCX CHLAMYDIA TRACHOMATIS ASSAY
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1993-09-27
Decision date
1995-12-08
Days to decision
802 days
Clearance type
Traditional
Product code
MKZ
Device class
1
Regulation number
866.3120
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174)Roche Diagnostics Corporation2007-04-16
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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
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