Atlas FDA

ABBOTT MODIFIED FACT PLUS PREGNANCY TEST

FDA 510(k) clearance K901981 · decided 1990-08-02

Clearance details

K-number
K901981
Device name
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1990-05-02
Decision date
1990-08-02
Days to decision
92 days
Clearance type
Traditional
Product code
LCX
Device class
2
Regulation number
862.1155
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (K243573)Assure Tech., LLC2025-01-15
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394)Andon Health Co, Ltd.2024-12-20
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (K240242)Anhui Deepblue Medical Technology Co., Ltd.2024-10-11
Shinetell Digital Pregnancy Test (K241978)Hangzhou AllTest Biotech Co., Ltd.2024-08-13
MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream (K240643)Guangzhou Decheng Biotechnology Co., Ltd.2024-06-21
Distinct® Digital Pregnancy Test (K232715)ACON Laboratories, Inc.2024-05-31
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx (K233624)Hangzhou Aichek Medical Technology Co., Ltd.2024-04-12
ACESO Early Pregnancy Test (K234152)Aceso Laboratories, Inc.2024-04-05

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