Company ยท US
Diagnostic Systems Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2006. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | 10 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 7 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 7 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 6 |
| CIZ | Radioimmunoassay, Androstenedione | 4 |
| JKR | Radioimmunoassay, Calcitonin | 4 |
| CGI | Radioimmunoassay, Estriol | 3 |
| CGR | Radioimmunoassay, Cortisol | 3 |
| CHP | Radioimmunoassay, Estradiol | 3 |
| CKG | Radioimmunoassay, Acth | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 |
| CGF | Radioimmunoassay, Estrone | 2 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 2 |
| CJM | Radioimmunoassay, Aldosterone | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2006 | K061758 | ACTIVE RENIN IRMA Diagnostic Systems Laboratories, Inc. | CIB |
| May 31, 2002 | K020945 | AXSYM INTACT PTH, MODEL 2G06 Diagnostic Systems Laboratories, Inc. | CEW |
| Mar 1, 2002 | K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 Diagnostic Systems Laboratories, Inc. | JHI |
| Dec 5, 2000 | K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 Diagnostic Systems Laboratories, Inc. | NDR |
| May 18, 2000 | K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 Diagnostic Systems Laboratories, Inc. | CDZ |
| Jun 21, 1999 | K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 Diagnostic Systems Laboratories, Inc. | LOJ |
| Nov 9, 1998 | K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 Diagnostic Systems Laboratories, Inc. | DCK |
| Aug 3, 1998 | K973244 | ACTIVE PSA IRMA (DSL-9700) Diagnostic Systems Laboratories, Inc. | LTJ |
| Aug 3, 1998 | K973243 | ACTIVE PSA ELISA (DSL-10-9700) Diagnostic Systems Laboratories, Inc. | LTJ |
| May 27, 1998 | K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 Diagnostic Systems Laboratories, Inc. | CIB |
| Oct 31, 1997 | K973514 | ACTIVE INTACT PTH Diagnostic Systems Laboratories, Inc. | CEW |
| Jun 16, 1997 | K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) Diagnostic Systems Laboratories, Inc. | CDZ |
| May 22, 1997 | K971270 | DSL ACTIVE T3 EIA Diagnostic Systems Laboratories, Inc. | CDP |
| May 22, 1997 | K971269 | DSL ACTIVE T4 EIA Diagnostic Systems Laboratories, Inc. | KLI |
| May 16, 1997 | K970915 | DSL ESTRONE-SULFATE RIA Diagnostic Systems Laboratories, Inc. | CGF |
| May 12, 1997 | K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| Apr 2, 1997 | K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) Diagnostic Systems Laboratories, Inc. | CFL |
| Sep 10, 1996 | K962895 | DSL DHEA-S-7 Diagnostic Systems Laboratories, Inc. | JKC |
| Sep 9, 1996 | K962118 | DSL ACTIVE FSH IRMA Diagnostic Systems Laboratories, Inc. | CGJ |
| Aug 30, 1996 | K962758 | DSL 9100 IGF-II IRMA Diagnostic Systems Laboratories, Inc. | CFL |
| Aug 23, 1996 | K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA Diagnostic Systems Laboratories, Inc. | CGI |
| Aug 16, 1996 | K963002 | ACTIVE ANDROSTENEDIONE EIA Diagnostic Systems Laboratories, Inc. | CIZ |
| Jun 28, 1996 | K961911 | DSL ACTIVE I-HCG ELISA Diagnostic Systems Laboratories, Inc. | JHI |
| May 15, 1996 | K955356 | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL Diagnostic Systems Laboratories, Inc. | CGI |
| May 7, 1996 | K960357 | DSL ACTIVE I-HCG IRMA Diagnostic Systems Laboratories, Inc. | JHI |
| Apr 26, 1996 | K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 Diagnostic Systems Laboratories, Inc. | CFT |
| Apr 23, 1996 | K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA Diagnostic Systems Laboratories, Inc. | CFL |
| Apr 5, 1996 | K961109 | ACTIVE LH IRMA Diagnostic Systems Laboratories, Inc. | CEP |
| Mar 28, 1996 | K960171 | ACTIVE CROSSLAPS ELISA Diagnostic Systems Laboratories, Inc. | JMM |
| Mar 6, 1996 | K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| Mar 6, 1996 | K960550 | ACTIVE T3 RIA Diagnostic Systems Laboratories, Inc. | CDP |
| Feb 29, 1996 | K960060 | DSL ACTIVE PROLACTIN IRMA Diagnostic Systems Laboratories, Inc. | CFT |
| Feb 23, 1996 | K955114 | DSL AACTIVE DHEA EIA KIT Diagnostic Systems Laboratories, Inc. | JKC |
| Oct 7, 1995 | K954312 | ACTIVE THYROXINE RIA Diagnostic Systems Laboratories, Inc. | CDX |
| Oct 2, 1995 | K953605 | ULTRA-SENSITIVE ESTRADIOL Diagnostic Systems Laboratories, Inc. | CHP |
| Jul 17, 1995 | K952281 | ACTIVE FREE TESTOSTERONE RIA Diagnostic Systems Laboratories, Inc. | CDZ |
| Jul 17, 1995 | K952199 | ACTIVE INTACT PTH ELISA Diagnostic Systems Laboratories, Inc. | CEW |
| May 10, 1995 | K951752 | ACTIVE IGF-I ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| May 10, 1995 | K951707 | DSL ACTIVE IFGBP-3 ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| Feb 22, 1995 | K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) Diagnostic Systems Laboratories, Inc. | CFL |
| Feb 13, 1995 | K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) Diagnostic Systems Laboratories, Inc. | CJM |
| Nov 10, 1994 | K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) Diagnostic Systems Laboratories, Inc. | JLX |
| Jul 6, 1994 | K930047 | DSL IGFBP-3 RIA (DSL 6700) Diagnostic Systems Laboratories, Inc. | CFL |
| Jun 16, 1994 | K935013 | DSL ESTRONE (DSL 8700) Diagnostic Systems Laboratories, Inc. | CGF |
| May 9, 1994 | K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) Diagnostic Systems Laboratories, Inc. | JKC |
| Jan 10, 1994 | K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE Diagnostic Systems Laboratories, Inc. | CIZ |
| Jul 10, 1992 | K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) Diagnostic Systems Laboratories, Inc. | CJM |
| May 26, 1992 | K921534 | DSL DHEA (DSL 8900) Diagnostic Systems Laboratories, Inc. | JKL |
| Mar 17, 1992 | K915823 | DSL ACTIVE SHBG (DSL 7400) Diagnostic Systems Laboratories, Inc. | CDZ |
| Mar 17, 1992 | K915508 | DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) Diagnostic Systems Laboratories, Inc. | JZG |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||