GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
FDA 510(k) clearance K771879 · decided 1977-10-19
Clearance details
- K-number
- K771879
- Device name
- GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1977-10-04
- Decision date
- 1977-10-19
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DEN
- Device class
- 1
- Regulation number
- 866.5420
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RID SYSTEM-HUMAN C-REACTIVE PROTEIN (K780325) | Icl Scientific | 1978-03-17 |
Recalls involving this device
No recalls on record reference this clearance.