FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK SURECELL HERPES (HSV) TEST KIT
K Number: K884680
·
Decision Feb 16, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
238
Review Days
99
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Basic Information
- Device Name
- KODAK SURECELL HERPES (HSV) TEST KIT
- K Number
- K884680
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Eastman Kodak Company
- Date Received
- November 9, 1988
- Decision Date
- February 16, 1989
- 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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MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
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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
FDA 510(k)
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THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
FDA 510(k)
FDA Class 2
·Microbiology
POCKIT HSV 2 RAPID TEST
FDA 510(k)
FDA Class 2
·Microbiology
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