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510(k) K782099

RIA TEST, NORDICALB HPL by Nordiclab Intl. — Product Code JMF

K782099 is an FDA 510(k) premarket notification submitted by Nordiclab Intl. for the device "RIA TEST, NORDICALB HPL". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code JMF (Radioimmunoassay, Human Placental Lactogen), a Class II device regulated under 21 CFR 862.1585. Nordiclab Intl. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1979
Date Received
December 18, 1978
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 Nordiclab Intl.

  • K801988 — NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (September 26, 1980)
  • K801989 — NORDICLAB FERRITIN IRMA TEST (September 16, 1980)
  • K800920 — NORDICLAB ESTRADIOL RIA TEST (May 14, 1980)
  • K800921 — NORDICLAB TESTOSTERONE RIA TEST (May 14, 1980)
  • K800922 — NORDICLAB PROGESTERONE RIA TEST (May 14, 1980)
  • K792189 — NORDICLAB TOTAL ESTRIOL RIA TEST (November 13, 1979)
  • K782157 — IRMA TEST, NORDICLAB FERRITIN (January 17, 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)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K771656 — PROLACTIN RIA DIAG. KIT (September 22, 1977)
  • K770659 — RIALYZE HPL (RIA) (May 20, 1977)

FDA data resources