FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K Number: K984343
·
Decision Jun 25, 1999
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
19
Applicant Total
92
Review Days
203
Basic Information
- Device Name
- PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
- K Number
- K984343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MERIDIAN DIAGNOSTICS, INC.
- Date Received
- December 4, 1998
- Decision Date
- June 25, 1999
- Product Code
- MXJ
- 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 |
|---|---|---|---|
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXJ), ordered by most recent decision date.
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys HSV-1 IgG (08948844160)
FDA 510(k)
FDA Class 2
·Microbiology
ADVIA Centaur Herpes-1 IgG
FDA 510(k)
FDA Class 2
·Microbiology
SeraQuest Herpes Type 1 Specific IgG
FDA 510(k)
FDA Class 2
·Microbiology
Theranos Herpes Simplex Virus-1 IgG Assay
FDA 510(k)
FDA Class 2
·Microbiology
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by MERIDIAN DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Dec 10, 1999 | Substantially Equivalent |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Aug 9, 1999 | Substantially Equivalent |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | Dec 17, 1998 | Substantially Equivalent |
| K982764 | PREMIER CRYPTOSPORIDIUM | Dec 3, 1998 | Substantially Equivalent |
| K982711 | PREMIER GIARDIA | Nov 25, 1998 | Substantially Equivalent |
| K980076 | PREMIER PLATINUM HPSA | May 12, 1998 | Substantially Equivalent |
| K980077 | PARA-PAK SPINCON | Apr 2, 1998 | Substantially Equivalent |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Aug 20, 1997 | Substantially Equivalent |
| K961508 | IMMUNOCARD H. PYLORI | Jan 21, 1997 | Substantially Equivalent |