Atlas FDA

TDX TOTAL ESTRIOL

FDA 510(k) clearance K844511 · decided 1985-01-18

Clearance details

K-number
K844511
Device name
TDX TOTAL ESTRIOL
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1984-11-20
Decision date
1985-01-18
Days to decision
59 days
Clearance type
Traditional
Product code
CGI
Device class
1
Regulation number
862.1265
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721)Bayer Corp.1998-03-03
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875)Diagnostic Systems Laboratories, Inc.1996-08-23
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356)Diagnostic Systems Laboratories, Inc.1996-05-15
COAT-A-COUNT FREE ESTRIOL (K932989)Diagnostic Products Corp.1994-12-19
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (K944490)Wallac OY1994-12-09
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (K920576)Eastman Kodak Company1992-03-23
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359)Immunotech Corp.1990-08-22
IMMPULSE FREE ESTRIOL ASSAY REAGENTS (K860900)Sclavo, Inc.1986-04-28
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (K850787)Nms Pharmaceuticals, Inc.1985-03-26
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (K844767)Biotecx Laboratories, Inc.1985-02-01
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED (K844408)Amersham Corp.1984-12-11
ENDAB ESTRIOL UNCONJUGATED (K840902)Immunotech Corp.1984-04-18

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