Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

94 results for "Diagnostic Systems Laboratories, Inc."
1–24 of 94
Search insights Median review: 58d Cleared: 100% Top manufacturer: Diagnostic Systems Laboratories, Inc. Lead specialty: Chemistry
Cleared Jul 28, 2006
ACTIVE RENIN IRMA
K061758 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 36d
Cleared May 31, 2002
AXSYM INTACT PTH, MODEL 2G06
K020945 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 67d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Dec 05, 2000
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · NDR
Diagnostic Systems Laboratories, Inc.
Chemistry · 144d
Cleared May 18, 2000
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086 · CDZ
Diagnostic Systems Laboratories, Inc.
Immunology · 44d
Cleared Jun 21, 1999
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138 · LOJ
Diagnostic Systems Laboratories, Inc.
Immunology · 153d
Cleared Nov 09, 1998
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871 · DCK
Diagnostic Systems Laboratories, Inc.
Immunology · 165d
Cleared Aug 03, 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared May 27, 1998
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 22d
Cleared Oct 31, 1997
ACTIVE INTACT PTH
K973514 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 44d
Cleared Jun 16, 1997
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared May 22, 1997
DSL ACTIVE T3 EIA
K971270 · CDP
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 22, 1997
DSL ACTIVE T4 EIA
K971269 · KLI
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 16, 1997
DSL ESTRONE-SULFATE RIA
K970915 · CGF
Diagnostic Systems Laboratories, Inc.
Chemistry · 65d
Cleared May 12, 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared Apr 02, 1997
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
K970701 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 35d
Cleared Sep 10, 1996
DSL DHEA-S-7
K962895 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 47d
Cleared Sep 09, 1996
DSL ACTIVE FSH IRMA
K962118 · CGJ
Diagnostic Systems Laboratories, Inc.
Chemistry · 101d
Cleared Aug 30, 1996
DSL 9100 IGF-II IRMA
K962758 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Aug 23, 1996
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K962875 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 30d
Cleared Aug 16, 1996
ACTIVE ANDROSTENEDIONE EIA
K963002 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 14d
Cleared Jun 28, 1996
DSL ACTIVE I-HCG ELISA
K961911 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared May 15, 1996
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
K955356 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 176d