Data / Medical devices / Canada / Pretium Canada Packaging ULC
Pretium Canada Packaging ULC: FDA-registered device maker in ETOBICOKE Ontario, Canada, 4 510(k) clearances
Pretium Canada Packaging ULC is registered with the FDA (registration 8020315) in ETOBICOKE Ontario, Canada. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 13, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020315
- FEI number
- 5804
- Address
- 50-A Steinway BLVD., ETOBICOKE Ontario, Canada, M9W 6Y3
- Owner or operator
- PRETIUM CANADA PACKAGING ULC (8020315)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 28, 1980
- Registered through
- 2026
- Brand names listed
- Histoplex Specimen Containers, Leakbuster, Leakbuster Space Saver, Multitrans System, Pinworm Collector (V302-PIN), Quick Turn, Spout Cap, Starswab Anaerobic Transport System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Contract manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Culture Media, Anaerobic Transport | JSL | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2003 | K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | JSM | Substantially Equivalent | Starplex Scientific, Inc. | accessdata.fda.gov |
| April 3, 1996 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | Substantially Equivalent | Starplex Scientific, Inc. | accessdata.fda.gov |
| February 16, 1995 | K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | JSL | Substantially Equivalent | Starplex Scientific, Inc. | accessdata.fda.gov |
| November 30, 1994 | K943499 | KULTSURE STARSWAB(M240), MODIFICATION | JSM | Substantially Equivalent | Ncs Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Sterile
- All makers of Container, Specimen, Non-Sterile
- All makers of Device, Specimen Collection
- All makers of Container, Liquid Medication, Graduated
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Culture Media, Anaerobic Transport
Updated August 13, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.