LetsGetChecked Inc
Cucamonga, CA, US
LetsGetChecked Inc appears in FDA device records in Cucamonga, CA. FDA records list no 510(k) clearances, 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
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 |
|---|---|---|---|---|---|
| 3042854290 | 3042854290 | LetsGetChecked Inc | Suite 300, 8407 Firebird Dr, Fairfield, OH 45011, USA, City View Heights, OH 45011 US | 2026 | |
| 3020139194 | 3020139194 | LetsGetChecked Inc. | 10825 7th Street, Suite A, Cucamonga, CA 91730 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- OYJDna Specimen Collection, Saliva
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- MXBTest, Vaginal, Bacterial Sialidase
- OIEUrine Collection Kit (Excludes Hiv Testing)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1212-2023 | LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples. | Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain