Dade RPR Card Test
FDA 510(k) K811152 · American Dade
510(k) numberK811152
Submission
- Device name
- Dade RPR Card Test
- Applicant
- American Dade
Mchenry, IL, US - Received
- April 27, 1981
- Decision date
- May 15, 1981
- 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
Other 510(k)s with product code GMQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Remel, L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K873051 | Stratus(R) HFSH Fluorometric Enzyme ImmunoassayCGJ · Traditional | 10/20/1987SE |
| K873171 | Stratus(R) Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 09/29/1987SE |
| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | 09/14/1987SE |
| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was Dade RPR Card Test cleared by the FDA?
Dade RPR Card Test (K811152) received a 510(k) decision of Substantially Equivalent on May 15, 1981, 18 days after the submission was received.
What is the product code of K811152?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.