Bhp Diagnostix, Inc.
Mchenry, IL, US
Bhp Diagnostix, Inc. appears in FDA device records in Mchenry, IL. FDA records list 25 510(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
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Bhp Diagnostix, Inc. between 1978 and 1990. The busiest year on record is 1979, with 11. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 7 |
| 1979 | 11 |
| 1984 | 2 |
| 1985 | 2 |
| 1986 | 2 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K904503 | SERACON CR REFERENCE | JJX | Substantially Equivalent | |
| K863648 | SERACON CT REFERENCE | JJY | Substantially Equivalent | |
| K862594 | SERACON(TM) CAL (PRODUCT NO. DO35) | JIX | Substantially Equivalent | |
| K844928 | QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE | JPK | Substantially Equivalent | |
| K844927 | QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS | JPK | Substantially Equivalent | |
| K844027 | SERACON TM SR III | JIX | Substantially Equivalent | |
| K844026 | SERACON TM SR IV | JIX | Substantially Equivalent | |
| K792487 | SERACON-SRII | JIX | Substantially Equivalent | |
| K792486 | SERACON-SRI (PROD. # D029 | JIX | Substantially Equivalent | |
| K792485 | SERACON-SRI | JIX | Substantially Equivalent | |
| K791958 | SERACON - EL DO27 | JJY | Substantially Equivalent | |
| K791957 | SERACON -LO DO26 | JJX | Substantially Equivalent | |
| K791956 | SERACON CAL D025 | JIX | Substantially Equivalent | |
| K782039 | SERACON-N | JIX | Substantially Equivalent | |
| K782170 | SERACON-LP | JJX | Substantially Equivalent | |
| K782171 | SERACON-HDL | JJX | Substantially Equivalent | |
| K782038 | SERACON-C | JJY | Substantially Equivalent | |
| K782037 | SERACON-A | JIX | Substantially Equivalent | |
| K781758 | SERACON-SRII | JIX | Substantially Equivalent | |
| K781757 | SERACON-SRI | JIX | Substantially Equivalent | |
| K781786 | QUANTICEL HHR # L500 AND L501 | JPK | Substantially Equivalent | |
| K781745 | QUANTICEL HHR, L531 AND L532 | JPK | Substantially Equivalent | |
| K781247 | QUANTICEL-HRP | JPK | Substantially Equivalent | |
| K780980 | PLATELET CONTROL | JPK | Substantially Equivalent | |
| K780714 | PLATELET CONTROL | JPK | 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