HSV IDR— 510(k) K854974
Substantially EquivalentGenus Diagnostics
FDA 510(k) clearance K854974 for HSV IDR, Substantially Equivalent on 1986-03-07. Applicant: Genus Diagnostics. Device class: 2.
Clearance details
- Applicant
- Genus Diagnostics
- Product code
- Code GQN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
Recent devices under product code GQN
view all- K070265 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
- K063798 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
- K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
- K971662 — ELVIS HSV ID/TYPING TEST SYSTEM
- K964874 — HSV-1 ANTIGEN CONTROL SLIDES
More clearances from Genus Diagnostics
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