FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREMIER GIARDIA
K Number: K982711
·
Decision Nov 25, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
26
Applicant Total
92
Review Days
113
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Basic Information
- Device Name
- PREMIER GIARDIA
- K Number
- K982711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Diagnostics, Inc.
- Date Received
- August 4, 1998
- Decision Date
- November 25, 1998
- Product Code
- MHI
- 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 |
|---|---|---|---|
| MHI | Giardia Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHI), ordered by most recent decision date.
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GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
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XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
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XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
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FDA Class 2
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GIARDIA II
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 |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 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 |
| 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 |