Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Laboratory Automation Systems, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
158 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | Medical Laboratory Automation Systems, Inc. | 1996-09-10 | 63 | 0 |
| K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER | Medical Laboratory Automation Systems, Inc. | 1995-02-03 | 155 | 0 |
| K931206 | ELECTRA 1600C AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1993-08-23 | 166 | 0 |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | 1992-09-29 | 90 | 0 |
| K903638 | GASTRO-INTESTINAL ACCU-CULSHURE TM | Medical Laboratory Automation Systems, Inc. | 1991-01-18 | 158 | 0 |
| K903406 | VIRAL ACCU-CULSHURE TM | Medical Laboratory Automation Systems, Inc. | 1990-10-16 | 77 | 0 |
| K903405 | CHLAMYDIA ACCU-CULSHURE TM | Medical Laboratory Automation Systems, Inc. | 1990-10-16 | 77 | 0 |
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | Medical Laboratory Automation Systems, Inc. | 1990-07-16 | 98 | 0 |
| K894052 | ELECTRA 1000C AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1989-07-27 | 50 | 0 |
| K884863 | ELECTRA 900C AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1989-02-03 | 74 | 0 |
| K871687 | TYTEM(R) REAGENT DISPENSER | Medical Laboratory Automation Systems, Inc. | 1987-05-20 | 21 | 0 |
| K864875 | ELECTRA AUTOMATIC SAMPLER | Medical Laboratory Automation Systems, Inc. | 1987-02-13 | 63 | 0 |
| K864534 | ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1987-02-06 | 81 | 0 |
| K864532 | ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1987-02-06 | 81 | 0 |
| K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1985-06-24 | 94 | 0 |
| K812124 | MLA ELECTRA 700 | Medical Laboratory Automation Systems, Inc. | 1981-10-02 | 67 | 0 |
| K780810 | MLA ELECTRA 750 COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1978-06-14 | 27 | 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