FDA 510(k) Applications for Medical Device Product Code "CFL"
(Radioimmunoassay, Human Growth Hormone)

FDA 510(k) Number Applicant Device Name Decision Date
K955376 DIAGNOSTIC PRODUCTS CORP. IMMULITE HGH 02/16/1996
K970701 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) 04/02/1997
K962758 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 9100 IGF-II IRMA 08/30/1996
K960551 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE HUMAN GROWTH HORMONE ELISA 03/06/1996
K961172 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE NON-EXTRACTION IGF-I IRMA 04/23/1996
K971353 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE NON-EXTRACTION IGF-I ELISA 05/12/1997
K961678 NICHOLS INSTITUTE DIAGNOSTICS HUMAN GROWTH HORMONE IMMUNOASSAY KIT 07/08/1996
K972761 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY 09/25/1997


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