FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSOM MONO TEST 143
K Number: K972231
·
Decision Aug 26, 1997
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
12
Review Days
71
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Basic Information
- Device Name
- OSOM MONO TEST 143
- K Number
- K972231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wyntek Diagnostics, Inc.
- Date Received
- June 16, 1997
- Decision Date
- August 26, 1997
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTN), ordered by most recent decision date.
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
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CLEARVIEW IM
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Other Clearances by Wyntek Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992658 | OSOM ULTRA STREP A TEST, MODEL 147 | Jan 18, 2000 | Substantially Equivalent |
| K990578 | OSOM CARD II HCG-URINE TEST, MODEL 102 | Mar 9, 1999 | Substantially Equivalent |
| K990576 | OSOM CARD PREGNANCY TEST, MODEL 103 | Mar 9, 1999 | Substantially Equivalent |
| K974159 | OSOM HCG-URINE TEST MODEL 101 | Dec 24, 1997 | Substantially Equivalent |
| K973879 | OSOM CARD HCG-URINE TEST | Nov 4, 1997 | Substantially Equivalent |
| K965227 | OSOM CLASSIC HCG-URINE TEST (115) | Feb 4, 1997 | Substantially Equivalent |
| K965184 | PERFECTA PREGNANCY TEST | Feb 4, 1997 | Substantially Equivalent |
| K961423 | OSOM STREP A TEST | Oct 11, 1996 | Substantially Equivalent |
| K955141 | OSOM HCG COMBO TEST | Dec 6, 1995 | Substantially Equivalent |
| K954178 | OSOM PREGNANCY TEST | Oct 23, 1995 | Substantially Equivalent |