Data / Medical devices / United States / Revvity Health Sciences, Inc.
Revvity Health Sciences, Inc.: FDA-registered device maker in Greenville, SC, United States, 1 510(k) clearance
Revvity Health Sciences, Inc. is registered with the FDA (registration 3007145015) in Greenville, SC, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 12, 2013. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007145015
- Address
- 17 P&N Drive, Greenville, SC, United States, 29611
- Owner or operator
- Revvity, Inc. (9912035)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 14, 2013
- Registered through
- 2026
- Brand names listed
- Contract Manufactured Collection Device with Ahlstrom 226 filter paper., Revvity 226 Sample Collection Device, Revvity Blood Collection Kit, Revvity GRNK1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Newborn Screening Specimen Collection Paper | PJC | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 12, 2013 | K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | PJC | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2017 | 85630 | Class III | Terminated | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. | accessdata.fda.gov |
| May 31, 2017 | 77668 | Class III | Terminated | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening. | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. | accessdata.fda.gov |
| September 5, 2013 | 66310 | Class II | Terminated | Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a l | Some devices may be contaminated on the back side of the device with glue in the blood application area. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Blood And Urine Collection Kit (Excludes Hiv Testing)
Updated March 12, 2013. 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.