FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V-TREND RPRL CARD TEST
K Number: K875180
·
Decision Feb 4, 1988
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
27
Review Days
49
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Basic Information
- Device Name
- V-TREND RPRL CARD TEST
- K Number
- K875180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Texas Immunology, Inc.
- Date Received
- December 17, 1987
- Decision Date
- February 4, 1988
- Product Code
- GMP
- 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 |
|---|---|---|---|
| GMP | Antisera, Control For Nontreponemal Tests | FDA class 2 | Microbiology |
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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 |