Medical Laboratory Automation Systems, Inc.
Mchenry, IL, US
Medical Laboratory Automation Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 17 510(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
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Medical Laboratory Automation Systems, Inc. between 1978 and 1996. The busiest year on record is 1987, with 4. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1981 | 1 |
| 1985 | 1 |
| 1987 | 4 |
| 1989 | 2 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | GKP | Substantially Equivalent | |
| K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER | GKP | Substantially Equivalent | |
| K931206 | ELECTRA 1600C AUTOMATIC COAGULATION TIMER | GKP | Substantially Equivalent | |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | GJA | Substantially Equivalent | |
| K903638 | GASTRO-INTESTINAL ACCU-CULSHURE TM | LIO | Substantially Equivalent | |
| K903406 | VIRAL ACCU-CULSHURE TM | LIO | Substantially Equivalent | |
| K903405 | CHLAMYDIA ACCU-CULSHURE TM | LIO | Substantially Equivalent | |
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | JTX | Substantially Equivalent | |
| K894052 | ELECTRA 1000C AUTOMATIC COAGULATION TIMER | GKP | Substantially Equivalent | |
| K884863 | ELECTRA 900C AUTOMATIC COAGULATION TIMER | GKP | Substantially Equivalent | |
| K871687 | TYTEM(R) REAGENT DISPENSER | JQW | Substantially Equivalent | |
| K864875 | ELECTRA AUTOMATIC SAMPLER | JQW | Substantially Equivalent | |
| K864534 | ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER | JPA | Substantially Equivalent | |
| K864532 | ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER | JPA | Substantially Equivalent | |
| K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER | KQG | Substantially Equivalent | |
| K812124 | MLA ELECTRA 700 | JPA | Substantially Equivalent | |
| K780810 | MLA ELECTRA 750 COAGULATION TIMER | JPA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain