FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPES GROUP IGG ELISA TEST SYSTEM
K Number: K963645
·
Decision Feb 4, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
68
Review Days
145
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Basic Information
- Device Name
- HERPES GROUP IGG ELISA TEST SYSTEM
- K Number
- K963645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Armkel, LLC
- Date Received
- September 12, 1996
- Decision Date
- February 4, 1997
- 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
FDA 510(k)
FDA Class 2
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MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
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FDA Class 2
·Microbiology
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
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HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
FDA 510(k)
FDA Class 2
·Microbiology
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
Other Clearances by Armkel, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | Oct 19, 2004 | Substantially Equivalent |
| K030258 | FIRST RESPONSE PREGNANCY TEST | Feb 25, 2003 | Substantially Equivalent |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | Dec 16, 2002 | Substantially Equivalent |
| K013433 | TROJAN PASSION BERRY GEL | Mar 5, 2002 | Substantially Equivalent |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 1, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |