FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
K Number: K982245
·
Decision Oct 6, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
26
Applicant Total
46
Review Days
102
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Basic Information
- Device Name
- TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
- K Number
- K982245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosite Incorporated
- Date Received
- June 26, 1998
- Decision Date
- October 6, 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.
UNIGOLD GIARDIA
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GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
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FDA Class 2
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GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
FDA 510(k)
FDA Class 2
·Microbiology
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
FDA 510(k)
FDA Class 2
·Microbiology
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
GIARDIA II
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Biosite Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Jun 11, 2010 | Substantially Equivalent |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Apr 19, 2010 | Substantially Equivalent |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | Nov 13, 2009 | Substantially Equivalent |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Jun 6, 2008 | Substantially Equivalent |
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | Dec 7, 2007 | Substantially Equivalent |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | Mar 1, 2007 | Substantially Equivalent |
| K062530 | TRIAGE PROTEIN C TEST | Jan 29, 2007 | Substantially Equivalent |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Jul 10, 2006 | Substantially Equivalent |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Jun 22, 2006 | Substantially Equivalent |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Jan 23, 2006 | Substantially Equivalent |