FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V-TREND EIA TSH
K Number: K861918
·
Decision Jul 2, 1986
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
22
Review Days
44
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Basic Information
- Device Name
- V-TREND EIA TSH
- K Number
- K861918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- V-Tech, Inc.
- Date Received
- May 19, 1986
- Decision Date
- July 2, 1986
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by V-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914303 | TARGET(TM)-HOG | Oct 11, 1991 | Substantially Equivalent |
| K910893 | TARGET(TM) CANNABINOIDS-R TEST | Apr 3, 1991 | Substantially Equivalent |
| K910892 | TARGET(TM) CANNABINOIDS-V TEST | Apr 3, 1991 | Substantially Equivalent |
| K910739 | TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) | Mar 21, 1991 | Substantially Equivalent |
| K910738 | TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) | Mar 19, 1991 | Substantially Equivalent |
| K910122 | TARGET COCAINE METABOLITE-R | Mar 19, 1991 | Substantially Equivalent |
| K910123 | TARGET COCAINE METABOLITE-V | Mar 19, 1991 | Substantially Equivalent |
| K903937 | TARGET(TM) HOG ONE STEP | Oct 22, 1990 | Substantially Equivalent |
| K890978 | TARGET OPIATES-R | Nov 17, 1989 | Substantially Equivalent |
| K890979 | TARGET OPIATES-V | Oct 4, 1989 | Substantially Equivalent |