FIBRINOGEN UPTAKE SYS -VARIOUS MODELS
FDA 510(k) clearance K834168 · decided 1983-12-29
Clearance details
- K-number
- K834168
- Device name
- FIBRINOGEN UPTAKE SYS -VARIOUS MODELS
- Applicant
- Canberra Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-04
- Decision date
- 1983-12-29
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JZD
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Meriden, CT, 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 |
|---|---|---|
| EAR SNARES (K822199) | Kelleher Corp. | 1982-08-25 |
Recalls involving this device
No recalls on record reference this clearance.