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Diagnostic Systems Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
94
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061758ACTIVE RENIN IRMAJuly 28, 2006
K020945AXSYM INTACT PTH, MODEL 2G06May 31, 2002
K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500March 1, 2002
K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100December 5, 2000
K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900May 18, 2000
K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400June 21, 1999
K981871C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100November 9, 1998
K973243ACTIVE PSA ELISA (DSL-10-9700)August 3, 1998
K973244ACTIVE PSA IRMA (DSL-9700)August 3, 1998
K981607ACTIVE RENIN IRMA MODEL NUMBER DSL-25100May 27, 1998
K973514ACTIVE INTACT PTHOctober 31, 1997
K971823ACTIVE TESTOSTERONE EIA (DSL-10-4000)June 16, 1997
K971270DSL ACTIVE T3 EIAMay 22, 1997
K971269DSL ACTIVE T4 EIAMay 22, 1997
K970915DSL ESTRONE-SULFATE RIAMay 16, 1997
K971353DSL ACTIVE NON-EXTRACTION IGF-I ELISAMay 12, 1997
K970701DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)April 2, 1997
K962895DSL DHEA-S-7September 10, 1996
K962118DSL ACTIVE FSH IRMASeptember 9, 1996
K962758DSL 9100 IGF-II IRMAAugust 30, 1996