Hemotec, Inc.
Mchenry, IL, US
Hemotec, Inc. appears in FDA device records in Mchenry, IL. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Hemotec, Inc. between 1980 and 1990. The busiest year on record is 1989, with 4. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 3 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | JBP | Substantially Equivalent | |
| K894466 | HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS | JPA | Substantially Equivalent | |
| K894359 | CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS | JPA | Substantially Equivalent | |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | JOX | Substantially Equivalent | |
| K884590 | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES | KFF | Substantially Equivalent | |
| K875089 | HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN | JPA | Substantially Equivalent | |
| K880302 | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER | GGN | Substantially Equivalent | |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | JOX | Substantially Equivalent | |
| K854376 | HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS | JPA | Substantially Equivalent | |
| K853789 | ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR | JPA | Substantially Equivalent | |
| K843459 | HEMOTEC ACT I SYSTEM | JBP | Substantially Equivalent | |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | JOX | Substantially Equivalent | |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | JOX | Substantially Equivalent | |
| K820410 | HEMOTEC HEPCON/SYSTEM FOUR & FOUR P | LOX | Substantially Equivalent | |
| K800161 | HEPCON/SYSTEM RC-10 | JOX | 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