FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPELISA KIT
K Number: K822883
·
Decision Jul 26, 1983
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
12
Review Days
306
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Basic Information
- Device Name
- HERPELISA KIT
- K Number
- K822883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- M.A. Bioproducts
- Date Received
- September 23, 1982
- Decision Date
- July 26, 1983
- 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
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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 M.A. Bioproducts
| K Number | Device Name | ||
|---|---|---|---|
| K823804 | MYCOPLASMELISA TEST KIT | May 25, 1983 | Substantially Equivalent |
| K830045 | MUMPSELISA TEST KIT | May 13, 1983 | Substantially Equivalent |
| K830615 | CYTOMEGELISA STAT | May 9, 1983 | Substantially Equivalent |
| K823805 | VARICELISA TEST KIT | May 5, 1983 | Substantially Equivalent |
| K821967 | CHLAMYDELISA TEST KIT | Aug 3, 1982 | Substantially Equivalent |
| K821762 | MEASELISA TEST KIT | Jul 30, 1982 | Substantially Equivalent |
| K813221 | TOXOELISA TEST KIT | Jan 26, 1982 | Substantially Equivalent |
| K812531 | CELL CULTURE REAGENTS | Oct 23, 1981 | Substantially Equivalent |
| K812123 | CYTOMEGELISA TEST KIT | Sep 23, 1981 | Substantially Equivalent |
| K802508 | RUBELISA IGM TEST KIT | Dec 18, 1980 | Substantially Equivalent |