The following data is part of a premarket notification filed by Guardian Scientific, Corp. with the FDA for Quix Rapid Pregnancy Strip Test.
| Device ID | K954993 |
| 510k Number | K954993 |
| Device Name: | QUIX RAPID PREGNANCY STRIP TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia, MD 21045 |
| Contact | Kathryn B Powers |
| Correspondent | Kathryn B Powers GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia, MD 21045 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-31 |
| Decision Date | 1995-12-13 |