FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERO/TEX MONO TEST
K Number: K821386
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
27
Review Days
53
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Basic Information
- Device Name
- SERO/TEX MONO TEST
- K Number
- K821386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Texas Immunology, Inc.
- Date Received
- May 10, 1982
- Decision Date
- July 2, 1982
- 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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Other Clearances by Texas Immunology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991465 | DRUG STOP | Dec 10, 1999 | Substantially Equivalent |
| K980153 | DRUG CHECK | Mar 27, 1998 | Substantially Equivalent |
| K973208 | FIRST SIGN | Oct 20, 1997 | Substantially Equivalent |
| K972094 | TARGET CARDIAC TROPONIN I TEST | Jul 23, 1997 | Substantially Equivalent |
| K963680 | TARGET MYOGLOBIN TEST | Feb 6, 1997 | Substantially Equivalent |
| K912246 | TARGET MICROALBUMINURIA TEST | Jul 19, 1991 | Substantially Equivalent |
| K910073 | TARGET ASO TEST | May 21, 1991 | Substantially Equivalent |
| K904105 | V-TREND TARGET RF TEST | Oct 15, 1990 | Substantially Equivalent |
| K892231 | V-TREND TARGET CRP TEST | Apr 21, 1989 | Substantially Equivalent |
| K890423 | V-TREND TARGET CRP TEST | Feb 17, 1989 | Substantially Equivalent |