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510(k) K802728

125I-TESTOSTERONE TEST SET by Wien Laboratories, Inc. — Product Code CDZ

K802728 is an FDA 510(k) premarket notification submitted by Wien Laboratories, Inc. for the device "125I-TESTOSTERONE TEST SET". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Wien Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 3, 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 Wien Laboratories, Inc.

  • K912850 — SHBG (August 12, 1991)
  • K834246 — PROGESTERONE TEST SET 125I 17-OH (February 4, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • K823200 — 125 I-DEHYDROEPIANDROSTERONE SULFATE (November 29, 1982)
  • K821652 — DOXEPIN TRI-CY TEST SET (June 14, 1982)
  • K821653 — PROTRIPTYLINE TRI-CY TEST SET (June 14, 1982)
  • K792041 — DHEA-SULFATE TEST SET (October 30, 1979)
  • K781834 — TEST SET, 125 I-DIGOXIN (January 3, 1979)
  • K781599 — I-ESTRIOL TEST SET (October 17, 1978)
  • K772306 — 125I DIGOXIN TEST SET (December 22, 1977)

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