Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Systems Laboratories, Inc.

94 submissions · 94 cleared · Since 1981
94
Total
94
Cleared
0
Denied

Diagnostic Systems Laboratories, Inc. — FDA 510(k) Submissions

Diagnostic Systems Laboratories, Inc. has submitted 94 FDA 510(k) premarket notifications since 1981, of which 94 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Human Growth Hormone, Radioimmunoassay, Testosterones And Dihydrotestosterone, Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate), Radioimmunoassay, Parathyroid Hormone, Radioimmunoassay, Calcitonin . Use the specialty filter in the sidebar to narrow results.

94 devices
1–25 of 94
ACTIVE RENIN IRMA
K061758 · CIB Radioimmunoassay,... · Chemistry
Jul 2006 36d
AXSYM INTACT PTH, MODEL 2G06
K020945 · CEW Radioimmunoassay,... · Chemistry
May 2002 67d
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · JHI Visual, Pregnancy Hcg,... · Chemistry
Mar 2002 45d
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · NDR Enzyme Immunoassay,... · Chemistry
Dec 2000 144d
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086 · CDZ Radioimmunoassay,... · Immunology
May 2000 44d
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138 · LOJ Kit,... · Immunology
Jun 1999 153d
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871 · DCK C-reactive Protein,... · Immunology
Nov 1998 165d
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · LTJ Prostate-specific Antigen... · Immunology
Aug 1998 339d
ACTIVE PSA IRMA (DSL-9700)
K973244 · LTJ Prostate-specific Antigen... · Immunology
Aug 1998 339d
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · CIB Radioimmunoassay,... · Chemistry
May 1998 22d
ACTIVE INTACT PTH
K973514 · CEW Radioimmunoassay,... · Chemistry
Oct 1997 44d
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · CDZ Radioimmunoassay,... · Chemistry
Jun 1997 31d
DSL ACTIVE T4 EIA
K971269 · KLI Enzyme Immunoassay,... · Chemistry
May 1997 48d
DSL ACTIVE T3 EIA
K971270 · CDP Radioimmunoassay, Total... · Chemistry
May 1997 48d
DSL ESTRONE-SULFATE RIA
K970915 · CGF Radioimmunoassay, Estrone · Chemistry
May 1997 65d
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · CFL Radioimmunoassay, Human... · Chemistry
May 1997 31d
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
K970701 · CFL Radioimmunoassay, Human... · Chemistry
Apr 1997 35d
DSL DHEA-S-7
K962895 · JKC Radioimmunoassay,... · Chemistry
Sep 1996 47d
DSL ACTIVE FSH IRMA
K962118 · CGJ Radioimmunoassay,... · Chemistry
Sep 1996 101d
DSL 9100 IGF-II IRMA
K962758 · CFL Radioimmunoassay, Human... · Chemistry
Aug 1996 45d
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K962875 · CGI Radioimmunoassay, Estriol · Chemistry
Aug 1996 30d
ACTIVE ANDROSTENEDIONE EIA
K963002 · CIZ Radioimmunoassay,... · Chemistry
Aug 1996 14d
DSL ACTIVE I-HCG ELISA
K961911 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jun 1996 42d
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
K955356 · CGI Radioimmunoassay, Estriol · Chemistry
May 1996 176d
DSL ACTIVE I-HCG IRMA
K960357 · JHI Visual, Pregnancy Hcg,... · Chemistry
May 1996 103d

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