510(k) K964687
- Device
- N LATEX CRP MONO REAGENT
- Applicant
- BEHRING DIAGNOSTICS, INC.
- 510(k) number
- K964687
- Product code
- DCH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-12-16
- Date received
- 1996-09-17
- Regulation
- 866.5270
- Classification name
- System, Test, C-reactive Protein, Rhodamine
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA LEBARRON
- Address
- 151 University Ave. Westwood MA US 02090 02090
FDA Registration Numbers#
- 3003601075
- 9610806
Source Documents#
Legacy Summary#
summary
FDA Review#
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