Sarstedt ApS
Newton, NC, US
SARSTEDT APS appears in FDA device records in Newton, NC. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sarstedt ApS between 1992 and 2005. The busiest year on record is 2003, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 2001 | 1 |
| 2003 | 3 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051019 | SAFETY NEEDLE | JKA | Substantially Equivalent | |
| K032150 | SAFETY-MULTIFLY | FPA | Substantially Equivalent | |
| K031359 | S-MONOVETTE EDTA K2-GEL | PJE | Substantially Equivalent | |
| K024237 | URINE MONOVETTE BORIC ACID | JSM | Substantially Equivalent | |
| K003382 | SARSTEDT NEEDLE PROTECTOR | FMI | Substantially Equivalent | |
| K913622 | HEMOPLUS | KHE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020703807 | 3020703807 | SARSTEDT APS | Brogesvej 18, Bording Midtjylland 7441 DK | 2026 | |
| 2242368 | 2242368 | SARSTEDT, INC. | 1025 Saint James Church Rd, NEWTON, NC 28658 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PJEBlood/Plasma Collection Device For Dna Testing
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- KDTContainer, Specimen Mailer And Storage, Sterile
- JSMCulture Media, Non-Propagating Transport
- KIZDish, Tissue Culture
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- GLEMixer, Blood Tube
- FMINeedle, Hypodermic, Single Lumen
- KHEReagent, Occult Blood
- FPASet, Administration, Intravascular
- GAXTourniquet, Nonpneumatic
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0114-2009 | Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet) | The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain