FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIRST SIGN
K Number: K973208
·
Decision Oct 20, 1997
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
27
Review Days
54
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Basic Information
- Device Name
- FIRST SIGN
- K Number
- K973208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Texas Immunology, Inc.
- Date Received
- August 27, 1997
- Decision Date
- October 20, 1997
- Product Code
- LCX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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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 |
| 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 |
| K890041 | V-TREND TARGET IM TEST | Jan 23, 1989 | Substantially Equivalent |