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510(k) K802661

LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT by Damon Corp. — Product Code CDZ

K802661 is an FDA 510(k) premarket notification submitted by Damon Corp. for the device "LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT". The FDA issued a decision of Substantially Equivalent on December 10, 1980. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Damon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1980
Date Received
October 28, 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 Damon Corp.

  • K874865 — DAMON D.E.T.E.C.T IMAGE ENHANCER (December 23, 1987)
  • K831826 — ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (July 18, 1983)
  • K820686 — LIQUISOL PROGESTERONE RADIOIMMUNO (April 1, 1982)
  • K790250 — LIQUISOL CORTISOL RIA TEST KIT (April 4, 1979)
  • K782124 — IEC CENTRA-7 CENTRIFUGE MODEL 2362 (February 26, 1979)
  • K781012 — RIA TEST KIT SYS. DAMON KIQUISOL FREE (July 27, 1978)
  • K780207 — LIQUISOL DIGOXIN RIA TEST KIT (February 23, 1978)
  • K770918 — LIQUI SOL T4 RIA TEST KIT (June 17, 1977)
  • K770606 — ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH (May 6, 1977)
  • K761013 — SPINETTE CENTRIFUGE (November 16, 1976)

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