510(k) K891093
- Device
- ACA (R) DIGITOXIN CALIBRATOR
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K891093
- Product code
- DCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-26
- Date received
- 1989-03-02
- Regulation
- 866.5160
- Classification name
- Beta-globulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD M VAUGHT
- Address
- Medical Products Dept. Barley Mill Plz., P22-1170 Wilmington DE US 19898 19898
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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