RedDrop ONE (One)
Reddrop DX
REDDROP INC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3026610069 | 3026610069 | REDDROP INC | 1 | Y | 2026-01-01 | 541 Tenth St., NW 2034 Atlanta GA US 30318 |
| 3030747802 | 3030747802 | REDDROP DX | 1 | N | 2026-01-01 | 2401 Research Blvd #206 Fort Collins CO US 80526 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 327749 | 1289431805 | K234081 | RedDrop ONE (One) | FMK | 2024-03-21 |
| 315248 | 1010116502 | ||||
| 315248 | 1426902156 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FMK | 1 | 2024-03-21 |
PMN
GUDID
RedDrop One - The RedDrop One is a single use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
2025-09-11
Scarlet - tampon
2025-05-16
RedDrop Dx - The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
2024-07-23