510(k) K895128
- Device
- BIOTRACK ALT TEST CARTRIDGE
- Applicant
- BIOTRACK, INC.
- 510(k) number
- K895128
- Product code
- CJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-06
- Date received
- 1989-08-17
- Regulation
- 862.1030
- Classification name
- Diazo, Alt/sgpt
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JILL FINDLAY
- Address
- 1058 Huff Ave. Mountain View CA US 94043 94043
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CJJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943003 | CALCIUM QVET | Prisma Systems | 1994-12-09 |
Legacy Summary#
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FDA Review#
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