510(k) K981592
- Device
- ACS:CENTAUR AFP
- Applicant
- CHIRON DIAGNOSTICS CORP.
- 510(k) number
- K981592
- Product code
- LOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-07-07
- Date received
- 1998-05-04
- Regulation
- 866.6010
- Classification name
- Device, General Purpose, Hematology
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS F FLYNN
- Address
- 63 N. St. Medfield MA US 02052 02052
FDA Registration Numbers#
- 8020888
- 1219913
- 2432235
Source Documents#
Legacy Summary#
summary
FDA Review#
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