510(k) K963139
- Device
- OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K963139
- Product code
- DDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-06
- Date received
- 1996-08-12
- Regulation
- 866.5880
- Classification name
- Transferrin, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- Two Corporate Center Dr. Melville NY US 11747 11747
FDA Registration Numbers#
- 9680746
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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