SULFATE, FIBRIQUIK PROTAMINE
FDA 510(k) clearance K781814 · decided 1978-11-08
Clearance details
- K-number
- K781814
- Device name
- SULFATE, FIBRIQUIK PROTAMINE
- Applicant
- General Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1978-10-26
- Decision date
- 1978-11-08
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- JBN
- Device class
- 2
- Regulation number
- 864.7300
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| FS TEST KIT (K854015) | American Bioproducts Co. | 1986-03-06 |
Recalls involving this device
No recalls on record reference this clearance.