510(k) K896829
- Device
- TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K896829
- Product code
- JGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-23
- Date received
- 1989-12-04
- Regulation
- 862.1665
- Classification name
- Flame Photometry, Sodium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- C BREWSTER
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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