HSV-2 ELISA IGG, MODEL EL0920G— 510(k) K993724
Substantially EquivalentMrl Diagnostics
FDA 510(k) clearance K993724 for HSV-2 ELISA IGG, MODEL EL0920G, Substantially Equivalent on 2000-02-01. Applicant: Mrl Diagnostics. Device class: 2.
Clearance details
- Applicant
- Mrl Diagnostics
- Product code
- Code MYF
- 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 MYF
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view all- K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
- K993754 — HSV-1 ELISA IGG, MODEL EL0910G
- 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
Adverse events under product code MYF
product code MYF- Injury
- 316
- Other
- 1
- Total
- 317
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.