RPR CARD TEST KIT— 510(k) K955136
Substantially EquivalentRemel, L.P.
FDA 510(k) clearance K955136 for RPR CARD TEST KIT, Substantially Equivalent on 1996-07-29. Applicant: Remel, L.P.. Device class: 2.
Clearance details
- Applicant
- Remel, L.P.
- 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
- Augusta, GA, 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 Remel, L.P.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.