Stanbio Syphilis RPR Test, No. 1170
FDA 510(k) K880144 · Stanbio Laboratory
510(k) numberK880144
Submission
- Device name
- Stanbio Syphilis RPR Test, No. 1170
- Applicant
- Stanbio Laboratory
San Antonio, TX, US - Received
- January 13, 1988
- Decision date
- May 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMQ – Antigens, Nontreponemal, All
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3820
- Specialty
- Microbiology
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|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics, LLC | 10/10/2025SE |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…GMQ · Traditional | Arlington Scientific, Inc. (Asi) | 10/21/2020SE |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionGMQ · Traditional | Arlington Scientific, Inc. (Asi) | 11/30/2018SE |
| K173376 | ASI EvolutionGMQ · Traditional | Arlington Scientific, Inc. (Asi) | 06/14/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics | 11/12/2015SE |
| K000687 | The Daya Syphilis Test/The Trust Antigen TestGMQ · Traditional | Beacon Biologicals, Inc. | 06/12/2000SE |
| K993633 | Synthetic VDRL AntigenGMQ · Traditional | Centers for Disease Control and Prevention | 02/23/2000SE |
| K992124 | Avanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar…GMQ · Traditional | Avanti Polar Lipids, Inc. | 09/20/1999SE |
| K954994 | TrustGMQ · Traditional | Guardian Scientific, Corp. | 10/18/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | Remel, L.P. | 07/29/1996SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special | 07/18/2008SE |
| K050283 | Creatinine LiquicolorJFY · Traditional | 06/30/2005SE |
| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorJFM · Traditional | 06/30/2005SE |
| K042169 | Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerJJE · Traditional | 03/14/2005SE |
| K041155 | Wide Range C-Reactive Protein (WR CRP) AssayDCK · Traditional | 10/14/2004SE |
| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
| K032932 | Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol CalibratorLBS · Traditional | 03/10/2004SE |
| K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Traditional | 10/24/2003SE |
| K020378 | Qupid Plus E.R.JHI · Traditional | 06/21/2002SE |
Questions and answers
When was Stanbio Syphilis RPR Test, No. 1170 cleared by the FDA?
Stanbio Syphilis RPR Test, No. 1170 (K880144) received a 510(k) decision of Substantially Equivalent on May 23, 1988, 131 days after the submission was received.
What is the product code of K880144?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.