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510(k) K800921

NORDICLAB TESTOSTERONE RIA TEST by Nordiclab Intl. — Product Code CDZ

K800921 is an FDA 510(k) premarket notification submitted by Nordiclab Intl. for the device "NORDICLAB TESTOSTERONE RIA TEST". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Nordiclab Intl. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
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)
  • 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)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)

Other clearances for product code CDZ

  • K252728 — IDS-iSYS Total Testosterone (April 15, 2026)
  • K240865 — IDS-iSYS Free Testosterone (October 23, 2024)
  • K233480 — Access SHBG (February 8, 2024)
  • K223405 — Access Testosterone (January 13, 2023)
  • K211685 — Elecsys Testosterone II (May 6, 2022)
  • K201908 — LIAISON Testosterone xt (October 15, 2020)
  • K191350 — ACTIVE® Free Testosterone RIA (December 20, 2019)
  • K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (August 28, 2019)
  • K190121 — IDS SHBG (June 17, 2019)
  • K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay (January 29, 2019)

FDA data resources