510(k) K780325
- Device
- RID SYSTEM-HUMAN C-REACTIVE PROTEIN
- Applicant
- ICL SCIENTIFIC
- 510(k) number
- K780325
- Product code
- DEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-03-17
- Date received
- 1978-02-27
- Regulation
- 866.5420
- Classification name
- Alpha-1-t-glycoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771879 | GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-19 |
Legacy Summary#
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FDA Review#
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