Home / 510(k) Clearances / K790919

510(k) K790919

HPL RIA KIT by Technia Diagnostics , Ltd. — Product Code JMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
May 14, 1979
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 Technia Diagnostics , Ltd.

  • K861978 — AUTOFLUOR V (June 10, 1986)
  • K801843 — T3(125) RADIOIMMUNOASSAY KIT (September 16, 1980)
  • K801202 — DIGOXIN RADIOIMMUNOASSAY KIT (June 20, 1980)
  • K801203 — CORTISOL RADIOIMMUNOASSAY KIT (June 9, 1980)
  • K791361 — T3 UPTAKE RADIOIMMUNOASSAY KIT (August 16, 1979)
  • K790495 — THYROXINE RIA KIT (May 3, 1979)
  • K782024 — RIA KIT, VITAMIN B12 (February 28, 1979)
  • K782025 — GENTAMICIN FLUROIMMUNASSAY KIT (January 26, 1979)

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)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)
  • K771656 — PROLACTIN RIA DIAG. KIT (September 22, 1977)
  • K770659 — RIALYZE HPL (RIA) (May 20, 1977)