ABBOTT IMX PROLACTIN— 510(k) K896162

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K896162 for ABBOTT IMX PROLACTIN, Substantially Equivalent on 1990-01-19. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1989-10-24
Decision date: 1990-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFT

K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA1997-06-24
K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS1997-02-25
K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN1997-02-20
K964748 — ELECSYS PROLACTIN ASSAY1997-01-21
K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-45001996-04-26

More clearances from Abbott Laboratories

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.