RID SYSTEM-HUMAN C-REACTIVE PROTEIN
FDA 510(k) clearance K780325 · decided 1978-03-17
Clearance details
- K-number
- K780325
- Device name
- RID SYSTEM-HUMAN C-REACTIVE PROTEIN
- Applicant
- Icl Scientific
- Decision
- Substantially Equivalent
- Date received
- 1978-02-27
- Decision date
- 1978-03-17
- Days to decision
- 18 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 |
|---|---|---|
| GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID (K771879) | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-19 |
Recalls involving this device
No recalls on record reference this clearance.