RPR Test for Syphilis in Serum or Plasma
FDA 510(k) K880477 · Ampcor, Inc.
510(k) numberK880477
Submission
- Device name
- RPR Test for Syphilis in Serum or Plasma
- Applicant
- Ampcor, Inc.
Bridgeport, NJ, US - Received
- February 4, 1988
- Decision date
- March 30, 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
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 |
|---|---|---|
| K922297 | Infectious Mononucleosis Qik-Dot Im Dry Card TestKTN · Traditional | 07/14/1992SE |
| K922296 | Imfectious Mononucleosis Im Liquid Card TestKTN · Traditional | 07/14/1992SE |
| K910438 | Dipstick SalmonellaGRM · Traditional | 09/13/1991SE |
| K893873 | Single and Dual Band Dipstick HCG TestDHA · Traditional | 08/21/1989SE |
| K890048 | Quik-Dot ToxoplasmosisLLA · Traditional | 06/09/1989SE |
| K892146 | C Reactive Protein LiquidDCK · Traditional | 04/14/1989SE |
| K892119 | Quik-Dot C Reactive ProteinDCK · Traditional | 04/14/1989SE |
| K890025 | Quik-Dot Antistreptolysin-OGTQ · Traditional | 01/31/1989SE |
| K884750 | Group a Strep, Beta-StrepGTZ · Traditional | 12/22/1988SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | 05/17/1988SE |
Questions and answers
When was RPR Test for Syphilis in Serum or Plasma cleared by the FDA?
RPR Test for Syphilis in Serum or Plasma (K880477) received a 510(k) decision of Substantially Equivalent on March 30, 1988, 55 days after the submission was received.
What is the product code of K880477?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.