TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA— 510(k) K880165
Substantially EquivalentAmpcor, Inc.
FDA 510(k) clearance K880165 for TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA, Substantially Equivalent on 1988-03-30. Applicant: Ampcor, Inc.. Device class: 2.
Clearance details
- Applicant
- Ampcor, Inc.
- Product code
- Code GMQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3820
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, NJ, US
Recent devices under product code GMQ
view all- K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
- K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
- K173376 — ASI Evolution
- K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
More clearances from Ampcor, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.