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510(k) K802454

GESTE FOLLOW KIT DETERM. OF HPL by Syn-Kit, Inc. — Product Code JMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 8, 1980
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 Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K861631 — SLIDE CULTURE U 'EIKEN' (June 10, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843756 — UROPAPER EIKEN 5 (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843759 — UROPAPER EIKEN HAG (December 18, 1984)

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)
  • K791854 — CENTRIA HPL RIA (October 1, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)
  • K771656 — PROLACTIN RIA DIAG. KIT (September 22, 1977)
  • K770659 — RIALYZE HPL (RIA) (May 20, 1977)