510(k) K980055
- Device
- CARESIDE GLOBULIN
- Applicant
- EXIGENT DIAGNOSTICS, INC.
- 510(k) number
- K980055
- Product code
- JGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-28
- Date received
- 1998-01-06
- Regulation
- 862.1330
- Classification name
- Turbidimetric Method, Globulin
- 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
- KENNETH B ASARCH
- Address
- 6100 Bristol Pkwy. Culver City CA US 90230 90230
Source Documents#
Legacy Summary#
summary
FDA Review#
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