Hettich Instruments LP
Beverly, MA, US
HETTICH INSTRUMENTS LP appears in FDA device records in Beverly, MA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Hettich Instruments LP carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Hettich Instruments Management Irecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004578971 | 3004578971 | HETTICH INSTRUMENTS LP | 100 Cummings Center #136L, Beverly, MA 01915 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0615-2010 | Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and TYP#201424-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. | Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. | Terminated | ||
| Z-0614-2010 | Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. | Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. | Terminated | ||
| Z-0613-2010 | Haematokrit 24 Centrifuge with 2050 Rotor TYP #2075 and TYP #2075-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. | Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. | Terminated | ||
| Z-0612-2010 | Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. | Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain