HSV-2 IGM ELISA TEST— 510(k) K910953
Substantially EquivalentGull Laboratories, Inc.
FDA 510(k) clearance K910953 for HSV-2 IGM ELISA TEST, Substantially Equivalent on 1991-05-28. Applicant: Gull Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Gull Laboratories, Inc.
- 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
- Salt Lake City, UT, 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
- K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
- K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
More clearances from Gull Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.