Medical Device Manufacturer · US , Newark , DE

Dade Chemistry Systems, Inc.

13 submissions · 13 cleared · Since 1996
13
Total
13
Cleared
0
Denied

Dade Chemistry Systems, Inc. — FDA 510(k) Submissions

Dade Chemistry Systems, Inc. has submitted 13 FDA 510(k) premarket notifications since 1996, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Secondary, Calibrator, Surrogate, Radioimmunoassay, Free Thyroxine, Single (specified) Analyte Controls (assayed And Unassayed), Prostate-specific Antigen (psa) For Management Of Prostate Cancers . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
TROPONIN (TROP) METHOD
K973650 · MMI Immunoassay Method,... · Chemistry
Oct 1997 25d
PROSTATE SPECIFIC ANTIGEN CONTROL
K973099 · JJX Single (specified)... · Immunology
Sep 1997 41d
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
K973100 · JIT Calibrator, Secondary · Immunology
Sep 1997 41d
PROSTATE SPECIFIC ANTIGEN METHOD
K973101 · LTJ Prostate-specific Antigen... · Immunology
Sep 1997 30d
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
K971141 · CEC Radioimmunoassay, Free... · Chemistry
Apr 1997 31d
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · DHA System, Test, Human... · Chemistry
Mar 1997 35d
MMB CALIBRATOR
K970336 · JIT Calibrator, Secondary · Chemistry
Mar 1997 33d
THYROID STIMULATING HORMONE METHOD
K970393 · JLW Radioimmunoassay,... · Chemistry
Mar 1997 28d
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
K970396 · JIW Calibrator, Surrogate · Chemistry
Feb 1997 17d
THYROID CALIBRATOR
K970389 · JIT Calibrator, Secondary · Chemistry
Feb 1997 15d
MMB METHOD
K970343 · JHY Colorimetric Method, Cpk... · Chemistry
Feb 1997 16d
FERR FLEX REAGENT CARTRIDGE
K963498 · JMG Radioimmunoassay... · Chemistry
Jan 1997 143d
FERRITIN CALIBRATOR
K963493 · JIT Calibrator, Secondary · Chemistry
Dec 1996 91d
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