510(k) K943003
- Device
- CALCIUM QVET
- Applicant
- PRISMA SYSTEMS
- 510(k) number
- K943003
- Product code
- CJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-12-09
- Date received
- 1994-06-23
- Regulation
- 862.1030
- Classification name
- Diazo, Alt/sgpt
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LARRY J BEASLEY
- Address
- 1721 Black River Blvd. Suite 200 Rome NY US 13440 13440
Source Documents#
Other 510(k) Records For Product Code CJJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Biotrack, Inc. | 1989-10-06 |
Legacy Summary#
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FDA Review#
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