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510(k) K915164

SRI TESTOSTERONE ENZYME IMMUNOASSAY by Serono-Baker Diagnostics, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
November 14, 1991
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 Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (November 30, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (March 2, 1992)
  • K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY (January 17, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (November 19, 1991)
  • K914462 — SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (October 23, 1991)
  • K911912 — SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (September 18, 1991)
  • K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (August 16, 1991)
  • K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (July 25, 1991)
  • K911396 — SR1 ESTRADIOL ENZYME IMMUNOASSAY (May 28, 1991)
  • K910837 — SRI TSH IMMUNENZYMETRIC ASSAY (May 24, 1991)

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