FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSOM STREP A TEST
K Number: K961423
·
Decision Oct 11, 1996
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
12
Review Days
182
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Basic Information
- Device Name
- OSOM STREP A TEST
- K Number
- K961423
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wyntek Diagnostics, Inc.
- Date Received
- April 12, 1996
- Decision Date
- October 11, 1996
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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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 |
| K972231 | OSOM MONO TEST 143 | Aug 26, 1997 | Substantially Equivalent |
| K965227 | OSOM CLASSIC HCG-URINE TEST (115) | Feb 4, 1997 | Substantially Equivalent |
| K965184 | PERFECTA PREGNANCY TEST | Feb 4, 1997 | Substantially Equivalent |
| K955141 | OSOM HCG COMBO TEST | Dec 6, 1995 | Substantially Equivalent |
| K954178 | OSOM PREGNANCY TEST | Oct 23, 1995 | Substantially Equivalent |