LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
FDA 510(k) clearance K771305 · decided 1977-08-04
Clearance details
- K-number
- K771305
- Device name
- LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
- Applicant
- Organon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-07-14
- Decision date
- 1977-08-04
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- GIM
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Organon
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GONOSTICON DRI-DOT TEST (N17985/S002) | Organon, Inc. | 1983-01-04 |
| GONOSTICON DRI-DOT (N17985/S001) | Organon, Inc. | 1981-04-14 |