FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K Number: K910499
·
Decision May 1, 1991
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
39
Review Days
85
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Basic Information
- Device Name
- IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
- K Number
- K910499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Vitek Systems, Inc.
- Date Received
- February 5, 1991
- Decision Date
- May 1, 1991
- Product Code
- LGC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGC), ordered by most recent decision date.
HERPES GROUP IGG
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DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
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HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
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THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
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POCKIT HSV 2 RAPID TEST
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Other Clearances by Vitek Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920661 | VIDAS CMV IGG ASSAY | Feb 12, 1993 | Substantially Equivalent |
| K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Jul 28, 1992 | Substantially Equivalent |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Apr 8, 1992 | Substantially Equivalent |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | Apr 7, 1992 | Substantially Equivalent |
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION | Mar 4, 1992 | Substantially Equivalent |
| K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY | Oct 11, 1991 | Substantially Equivalent |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Sep 23, 1991 | Substantially Equivalent |
| K910230 | LYME-SPOT IF KIT | Aug 30, 1991 | Substantially Equivalent |
| K910210 | SLIDEX MENINGITE-KIT 5 | Aug 12, 1991 | Substantially Equivalent |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Jul 26, 1991 | Substantially Equivalent |