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Serono-Baker Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K924257 TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYCDZ1992-11-30 View
510(k) K915164 SRI TESTOSTERONE ENZYME IMMUNOASSAYCDZ1992-03-02 View
510(k) K914886 SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)CGR1992-03-02 View
510(k) K915602 SRI DIGOXIN ENZYME IMMUNOASSAYKXT1992-01-17 View
510(k) K912937 SR1 FREE T4 ENZYME IMMUNOASSAYCEC1991-11-19 View
510(k) K914462 SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)JLS1991-10-23 View
510(k) K911912 SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)KHQ1991-09-18 View
510(k) K911217 SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)KLI1991-08-16 View
510(k) K912318 ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)CHP1991-07-25 View
510(k) K911396 SR1 ESTRADIOL ENZYME IMMUNOASSAYCHP1991-05-28 View
510(k) K910837 SRI TSH IMMUNENZYMETRIC ASSAYJLW1991-05-24 View
510(k) K910737 SRI T3 IMMOENZYMETRIC ASSAYCDP1991-05-01 View
510(k) K911175 SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)DBF1991-04-05 View
510(k) K903975 SEROZYME CORTISOL TEST KITCGR1991-01-23 View
510(k) K896145 ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAYCHP1989-12-27 View
510(k) K894175 SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAYJHI1989-12-19 View
510(k) K895380 SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAYCFT1989-10-17 View
510(k) K893605 SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAYCEP1989-06-20 View
510(k) K892706 SR1 (FSH) IMMUNOENZYMETRIC ASSAYCGJ1989-06-09 View
510(k) K890645 ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KITCHP1989-03-08 View
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