Diagnostic Systems Laboratories, Inc.
Webster, TX, US
Diagnostic Systems Laboratories, Inc. appears in FDA device records in Webster, TX. FDA records list 94 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 94
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for Diagnostic Systems Laboratories, Inc. between 1981 and 2006. The busiest year on record is 1996, with 16. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 5 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 9 |
| 1986 | 4 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 6 |
| 1991 | 2 |
| 1992 | 6 |
| 1994 | 5 |
| 1995 | 8 |
| 1996 | 16 |
| 1997 | 7 |
| 1998 | 4 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 2 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061758 | ACTIVE RENIN IRMA | CIB | Substantially Equivalent | |
| K020945 | AXSYM INTACT PTH, MODEL 2G06 | CEW | Substantially Equivalent | |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | JHI | Substantially Equivalent | |
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | NDR | Substantially Equivalent | |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | CDZ | Substantially Equivalent | |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | LOJ | Substantially Equivalent | |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | DCK | Substantially Equivalent | |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | LTJ | Substantially Equivalent | |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | LTJ | Substantially Equivalent | |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | CIB | Substantially Equivalent | |
| K973514 | ACTIVE INTACT PTH | CEW | Substantially Equivalent | |
| K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) | CDZ | Substantially Equivalent | |
| K971270 | DSL ACTIVE T3 EIA | CDP | Substantially Equivalent | |
| K971269 | DSL ACTIVE T4 EIA | KLI | Substantially Equivalent | |
| K970915 | DSL ESTRONE-SULFATE RIA | CGF | Substantially Equivalent | |
| K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA | CFL | Substantially Equivalent | |
| K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) | CFL | Substantially Equivalent | |
| K962895 | DSL DHEA-S-7 | JKC | Substantially Equivalent | |
| K962118 | DSL ACTIVE FSH IRMA | CGJ | Substantially Equivalent | |
| K962758 | DSL 9100 IGF-II IRMA | CFL | Substantially Equivalent | |
| K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | CGI | Substantially Equivalent | |
| K963002 | ACTIVE ANDROSTENEDIONE EIA | CIZ | Substantially Equivalent | |
| K961911 | DSL ACTIVE I-HCG ELISA | JHI | Substantially Equivalent | |
| K955356 | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL | CGI | Substantially Equivalent | |
| K960357 | DSL ACTIVE I-HCG IRMA | JHI | Substantially Equivalent | |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | CFT | Substantially Equivalent | |
| K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA | CFL | Substantially Equivalent | |
| K961109 | ACTIVE LH IRMA | CEP | Substantially Equivalent | |
| K960171 | ACTIVE CROSSLAPS ELISA | JMM | Substantially Equivalent | |
| K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA | CFL | Substantially Equivalent | |
| K960550 | ACTIVE T3 RIA | CDP | Substantially Equivalent | |
| K960060 | DSL ACTIVE PROLACTIN IRMA | CFT | Substantially Equivalent | |
| K955114 | DSL AACTIVE DHEA EIA KIT | JKC | Substantially Equivalent | |
| K954312 | ACTIVE THYROXINE RIA | CDX | Substantially Equivalent | |
| K953605 | ULTRA-SENSITIVE ESTRADIOL | CHP | Substantially Equivalent | |
| K952281 | ACTIVE FREE TESTOSTERONE RIA | CDZ | Substantially Equivalent | |
| K952199 | ACTIVE INTACT PTH ELISA | CEW | Substantially Equivalent | |
| K951752 | ACTIVE IGF-I ELISA | CFL | Substantially Equivalent | |
| K951707 | DSL ACTIVE IFGBP-3 ELISA | CFL | Substantially Equivalent | |
| K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) | CFL | Substantially Equivalent | |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | CJM | Substantially Equivalent | |
| K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | JLX | Substantially Equivalent | |
| K930047 | DSL IGFBP-3 RIA (DSL 6700) | CFL | Substantially Equivalent | |
| K935013 | DSL ESTRONE (DSL 8700) | CGF | Substantially Equivalent | |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | JKC | Substantially Equivalent | |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | CIZ | Substantially Equivalent | |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | CJM | Substantially Equivalent | |
| K921534 | DSL DHEA (DSL 8900) | JKL | Substantially Equivalent | |
| K915823 | DSL ACTIVE SHBG (DSL 7400) | CDZ | Substantially Equivalent | |
| K915508 | DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) | JZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
- GGTAssay, Erythropoietin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JITCalibrator, Secondary
- JHTChromatographic Separation, Cpk Isoenzymes
- JMMColumn Chromatography & Color Development, Hydroxyproline
- NDREnzyme Immunoassay, Inhibin-A
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DBFFerritin, Antigen, Antiserum, Control
- JHXFluorometric Method, Cpk Or Isoenzymes
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- CIAMethylthymol Blue, Calcium
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CKGRadioimmunoassay, Acth
- CJMRadioimmunoassay, Aldosterone
- CIZRadioimmunoassay, Androstenedione
- CIBRadioimmunoassay, Angiotensin I And Renin
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKRRadioimmunoassay, Calcitonin
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGFRadioimmunoassay, Estrone
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CFLRadioimmunoassay, Human Growth Hormone
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- JHWU.V. Method, Cpk Isoenzymes
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Diagnostic Systems Laboratories, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Diagnostic Systems Laboratories, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain