Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Systems Laboratories, Inc. — Predicate Candidate Screening
94 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
171 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061758 | ACTIVE RENIN IRMA | Diagnostic Systems Laboratories, Inc. | 2006-07-28 | 36 | 0 |
| K020945 | AXSYM INTACT PTH, MODEL 2G06 | Diagnostic Systems Laboratories, Inc. | 2002-05-31 | 67 | 0 |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | Diagnostic Systems Laboratories, Inc. | 2002-03-01 | 45 | 0 |
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | Diagnostic Systems Laboratories, Inc. | 2000-12-05 | 144 | 4 |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | Diagnostic Systems Laboratories, Inc. | 2000-05-18 | 44 | 0 |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Diagnostic Systems Laboratories, Inc. | 1999-06-21 | 153 | 0 |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | Diagnostic Systems Laboratories, Inc. | 1998-11-09 | 165 | 0 |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | Diagnostic Systems Laboratories, Inc. | 1998-08-03 | 339 | 0 |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | Diagnostic Systems Laboratories, Inc. | 1998-08-03 | 339 | 0 |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | Diagnostic Systems Laboratories, Inc. | 1998-05-27 | 22 | 1 |
| K973514 | ACTIVE INTACT PTH | Diagnostic Systems Laboratories, Inc. | 1997-10-31 | 44 | 0 |
| K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) | Diagnostic Systems Laboratories, Inc. | 1997-06-16 | 31 | 0 |
| K971270 | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 | 48 | 0 |
| K971269 | DSL ACTIVE T4 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 | 48 | 0 |
| K970915 | DSL ESTRONE-SULFATE RIA | Diagnostic Systems Laboratories, Inc. | 1997-05-16 | 65 | 0 |
| K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | 1997-05-12 | 31 | 0 |
| K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) | Diagnostic Systems Laboratories, Inc. | 1997-04-02 | 35 | 0 |
| K962895 | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | 1996-09-10 | 47 | 0 |
| K962118 | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-09-09 | 101 | 0 |
| K962758 | DSL 9100 IGF-II IRMA | Diagnostic Systems Laboratories, Inc. | 1996-08-30 | 45 | 0 |
| K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-23 | 30 | 0 |
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-16 | 14 | 0 |
| K961911 | DSL ACTIVE I-HCG ELISA | Diagnostic Systems Laboratories, Inc. | 1996-06-28 | 42 | 0 |
| K955356 | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL | Diagnostic Systems Laboratories, Inc. | 1996-05-15 | 176 | 0 |
| K960357 | DSL ACTIVE I-HCG IRMA | Diagnostic Systems Laboratories, Inc. | 1996-05-07 | 103 | 0 |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | Diagnostic Systems Laboratories, Inc. | 1996-04-26 | 77 | 1 |
| K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-23 | 29 | 0 |
| K961109 | ACTIVE LH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-05 | 16 | 0 |
| K960171 | ACTIVE CROSSLAPS ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-28 | 72 | 0 |
| K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 | 27 | 0 |
| K960550 | ACTIVE T3 RIA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 | 27 | 0 |
| K960060 | DSL ACTIVE PROLACTIN IRMA | Diagnostic Systems Laboratories, Inc. | 1996-02-29 | 56 | 0 |
| K955114 | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | 1996-02-23 | 106 | 0 |
| K954312 | ACTIVE THYROXINE RIA | Diagnostic Systems Laboratories, Inc. | 1995-10-07 | 22 | 0 |
| K953605 | ULTRA-SENSITIVE ESTRADIOL | Diagnostic Systems Laboratories, Inc. | 1995-10-02 | 61 | 0 |
| K952281 | ACTIVE FREE TESTOSTERONE RIA | Diagnostic Systems Laboratories, Inc. | 1995-07-17 | 62 | 0 |
| K952199 | ACTIVE INTACT PTH ELISA | Diagnostic Systems Laboratories, Inc. | 1995-07-17 | 68 | 2 |
| K951752 | ACTIVE IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | 1995-05-10 | 23 | 0 |
| K951707 | DSL ACTIVE IFGBP-3 ELISA | Diagnostic Systems Laboratories, Inc. | 1995-05-10 | 27 | 1 |
| K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) | Diagnostic Systems Laboratories, Inc. | 1995-02-22 | 42 | 1 |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1995-02-13 | 214 | 0 |
| K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | Diagnostic Systems Laboratories, Inc. | 1994-11-10 | 133 | 0 |
| K930047 | DSL IGFBP-3 RIA (DSL 6700) | Diagnostic Systems Laboratories, Inc. | 1994-07-06 | 547 | 0 |
| K935013 | DSL ESTRONE (DSL 8700) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 | 239 | 4 |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | 1994-05-09 | 201 | 0 |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Diagnostic Systems Laboratories, Inc. | 1994-01-10 | 98 | 0 |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1992-07-10 | 120 | 0 |
| K921534 | DSL DHEA (DSL 8900) | Diagnostic Systems Laboratories, Inc. | 1992-05-26 | 56 | 1 |
| K915508 | DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) | Diagnostic Systems Laboratories, Inc. | 1992-03-17 | 99 | 0 |
| K915823 | DSL ACTIVE SHBG (DSL 7400) | Diagnostic Systems Laboratories, Inc. | 1992-03-17 | 78 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda