Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dynatech Laboratories, Inc. — Predicate Candidate Screening
44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
91 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962265 | MLX MICROTITER PLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1996-07-25 | 43 | 0 |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Dynatech Laboratories, Inc. | 1994-11-02 | 456 | 0 |
| K943701 | MRX MICROPLATE READER | Dynatech Laboratories, Inc. | 1994-10-20 | 83 | 0 |
| K923456 | MICROLITE MICROTITER PLATE LUMINOMETER ML3000 | Dynatech Laboratories, Inc. | 1992-10-13 | 91 | 0 |
| K915896 | MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI | Dynatech Laboratories, Inc. | 1992-05-04 | 137 | 0 |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Dynatech Laboratories, Inc. | 1992-03-19 | 37 | 0 |
| K913590 | MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1991-10-25 | 74 | 0 |
| K895313 | MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER | Dynatech Laboratories, Inc. | 1989-10-17 | 49 | 0 |
| K894645 | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | Dynatech Laboratories, Inc. | 1989-10-17 | 85 | 0 |
| K894687 | DYNATECH MR 5000, CATALOG #011-976-0600 | Dynatech Laboratories, Inc. | 1989-08-31 | 37 | 0 |
| K890502 | MICROLITE TUBE LUMINOMETER #011-902-0000 | Dynatech Laboratories, Inc. | 1989-02-27 | 26 | 0 |
| K884782 | MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000) | Dynatech Laboratories, Inc. | 1989-02-17 | 94 | 0 |
| K881195 | DYNATECH SPD 2000, NUMBER 002-910-0000 | Dynatech Laboratories, Inc. | 1988-06-07 | 78 | 0 |
| K881675 | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS | Dynatech Laboratories, Inc. | 1988-04-21 | 3 | 0 |
| K874598 | DYNATECH MR 250 MANUAL MICROELISA READER | Dynatech Laboratories, Inc. | 1987-11-20 | 11 | 0 |
| K874244 | DYNATECH MR 300 MANUAL MICROELISA | Dynatech Laboratories, Inc. | 1987-11-03 | 18 | 0 |
| K872363 | DYNATECH SPD 3000, #002-900-0000 | Dynatech Laboratories, Inc. | 1987-07-16 | 28 | 0 |
| K871415 | MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) | Dynatech Laboratories, Inc. | 1987-04-22 | 14 | 0 |
| K864863 | DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) | Dynatech Laboratories, Inc. | 1987-01-13 | 33 | 0 |
| K863623 | ULTRAWASH I | Dynatech Laboratories, Inc. | 1986-10-21 | 35 | 0 |
| K863624 | ULTRAWASH II | Dynatech Laboratories, Inc. | 1986-10-21 | 35 | 0 |
| K862802 | MULTI-CHANNEL MICROPIPETTES | Dynatech Laboratories, Inc. | 1986-08-01 | 10 | 0 |
| K854423 | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES | Dynatech Laboratories, Inc. | 1985-11-20 | 15 | 0 |
| K854303 | MR 700 MICROPLATE READER 012-700-1000 | Dynatech Laboratories, Inc. | 1985-11-19 | 25 | 0 |
| K852411 | MR 650 MICROPLATE READER(CAT. NO. 011-973-0500) | Dynatech Laboratories, Inc. | 1985-09-30 | 116 | 0 |
| K843272 | T.I.M.E. DISPENSER | Dynatech Laboratories, Inc. | 1984-09-14 | 25 | 0 |
| K823218 | DISPOSABLE DISPENSE MANIFOLD | Dynatech Laboratories, Inc. | 1982-11-16 | 19 | 0 |
| K800989 | DYNAWASHER II | Dynatech Laboratories, Inc. | 1980-06-02 | 39 | 0 |
| K801018 | IMMULON 1, #11-010-3350 & IMMULON 2 #-- | Dynatech Laboratories, Inc. | 1980-05-14 | 14 | 0 |
| K800522 | MICRO ELISA AUTO READER | Dynatech Laboratories, Inc. | 1980-03-25 | 19 | 0 |
| K800057 | MICRO ELISA MINI READER | Dynatech Laboratories, Inc. | 1980-02-11 | 32 | 0 |
| K791302 | MANUAL MICRO ELISA READER #2-530 | Dynatech Laboratories, Inc. | 1979-08-16 | 37 | 0 |
| K790958 | 120 WELL HISTO-PLATE | Dynatech Laboratories, Inc. | 1979-06-28 | 37 | 0 |
| K791049 | SYNALON ROLLER BOTTLE | Dynatech Laboratories, Inc. | 1979-06-28 | 22 | 0 |
| K790974 | MIC-2000 INOCULATOR TEMPLATE | Dynatech Laboratories, Inc. | 1979-06-20 | 28 | 0 |
| K790971 | MIC-2000 QUAD INOCULUM TRAY | Dynatech Laboratories, Inc. | 1979-06-20 | 29 | 0 |
| K790956 | HISTO-OILER | Dynatech Laboratories, Inc. | 1979-06-15 | 24 | 0 |
| K790957 | HISTO-DISPENSER | Dynatech Laboratories, Inc. | 1979-06-15 | 24 | 0 |
| K782130 | MINI-DILUTER 2 | Dynatech Laboratories, Inc. | 1979-02-15 | 50 | 0 |
| K790076 | INOCULATOR, MIC-2000 DISPOSABLE | Dynatech Laboratories, Inc. | 1979-02-01 | 20 | 0 |
| K781942 | MINIWASH | Dynatech Laboratories, Inc. | 1978-12-04 | 17 | 0 |
| K781646 | SRD-2 | Dynatech Laboratories, Inc. | 1978-10-27 | 32 | 0 |
| K781645 | AUTODILUTER 2 | Dynatech Laboratories, Inc. | 1978-10-27 | 32 | 0 |
| K780305 | CELL | Dynatech Laboratories, Inc. | 1978-03-27 | 32 | 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