HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G— 510(k) K000238
Substantially EquivalentMrl Diagnostics
FDA 510(k) clearance K000238 for HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G, Substantially Equivalent on 2000-04-14. Applicant: Mrl Diagnostics. Device class: 2.
Clearance details
- Applicant
- Mrl Diagnostics
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code LGC
view all- K033059 — HERPES GROUP IGG
- K010878 — MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
- K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
- K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K983886 — POCKIT HSV 2 RAPID TEST
More clearances from Mrl Diagnostics
view all- K993754 — HSV-1 ELISA IGG, MODEL EL0910G
- K993724 — HSV-2 ELISA IGG, MODEL EL0920G
- K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
- K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
- K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.