FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TARGET READER
K Number: K885254
·
Decision Jan 27, 1989
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
17
Applicant Total
22
Review Days
35
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Basic Information
- Device Name
- TARGET READER
- K Number
- K885254
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2400
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- V-Tech, Inc.
- Date Received
- December 23, 1988
- Decision Date
- January 27, 1989
- Product Code
- JQT
- 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 |
|---|---|---|---|
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQT), ordered by most recent decision date.
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FDA 510(k)
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APOLLO DENSITOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |