Home / 510(k) Clearances / K771656

510(k) K771656

PROLACTIN RIA DIAG. KIT by Abbott Laboratories — Product Code JMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1977
Date Received
August 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Placental Lactogen
Device Class
Class II
Regulation Number
862.1585
Review Panel
CH
Submission Type

Other clearances by Abbott Laboratories

  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K232669 — TBI (September 29, 2023)
  • K222850 — HAVAb IgG II (August 10, 2023)
  • K220031 — Alinity h-series System (August 4, 2023)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)

Other clearances for product code JMF

  • K944933 — IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (March 10, 1995)
  • K840588 — AMERLEX HUMAN PLACENTAL LACTOGEN (April 4, 1984)
  • K823292 — IMMOPHASE TM HPL RADIOIMMUNOASSAY (December 28, 1982)
  • K823201 — HUMAN PLACENTAL LACTOGEN KIT (November 29, 1982)
  • K811370 — NATAL-TEC HPL (May 29, 1981)
  • K802454 — GESTE FOLLOW KIT DETERM. OF HPL (November 12, 1980)
  • K791854 — CENTRIA HPL RIA (October 1, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)
  • K770659 — RIALYZE HPL (RIA) (May 20, 1977)