FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COUNT-10 STAIN
K Number: K823363
·
Decision Dec 15, 1982
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
0
Applicant Total
22
Review Days
36
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Basic Information
- Device Name
- COUNT-10 STAIN
- K Number
- K823363
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- V-Tech, Inc.
- Date Received
- November 9, 1982
- Decision Date
- December 15, 1982
- Product Code
- LEE
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LEE | Stains, Dye Solution | FDA class 1 | Hematology |
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 |