510(k) K771879
- Device
- GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
- Applicant
- HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
- 510(k) number
- K771879
- Product code
- DEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-19
- Date received
- 1977-10-04
- 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 |
|---|---|---|---|
| K780325 | RID SYSTEM-HUMAN C-REACTIVE PROTEIN | Icl Scientific | 1978-03-17 |
Legacy Summary#
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FDA Review#
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