510(k) BK200488
- Device
- Antigens, Nontreponemal, All
- Applicant
- Arlington Scientific, Inc.
- 510(k) number
- BK200488
- Product code
- GMQ
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2020-09-30
- Date received
- 2020-06-04
- Regulation
- 866.3820
- Classification name
- Antigens, Nontreponemal, All
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code GMQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | 2025-10-10 |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | Arlington Scientific, Inc. (Asi) | 2020-10-21 |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-11-30 |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-06-14 |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics | 2015-11-12 |
| K000687 | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST | Beacon Biologicals, Inc. | 2000-06-12 |
| K993633 | SYNTHETIC VDRL ANTIGEN | Centers for Disease Control and Prevention | 2000-02-23 |
| K992124 | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI | Avanti Polar Lipids, Inc. | 1999-09-20 |
| K954994 | TRUST | Guardian Scientific, Corp. | 1996-10-18 |
| K955136 | RPR CARD TEST KIT | Remel, L.P. | 1996-07-29 |
| K952802 | VISUWELL REAGIN II | Biomira Diagnostics, Inc. | 1996-05-23 |
| K910541 | BIOKIT RPR | Biokit USA, Inc. | 1991-10-18 |
| K904496 | CROMATEST SYPHILIS DIAGNOSTIC | Biotrax, Inc. | 1991-07-24 |
| K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) | Adi Diagnostics, Inc. | 1990-04-10 |
| K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | Stanbio Laboratory | 1988-05-23 |
Legacy Summary#
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FDA Review#
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