ACA FIBRINOGEN CALIBRATOR
FDA 510(k) clearance K812628 · decided 1981-11-24
Clearance details
- K-number
- K812628
- Device name
- ACA FIBRINOGEN CALIBRATOR
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-15
- Decision date
- 1981-11-24
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- GFX
- Device class
- 2
- Regulation number
- 864.7340
- 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 |
|---|---|---|
| FIBRINOGEN CALIBRATOR KIT (K072304) | Dade Behring, Inc. | 2007-09-19 |
| FIBRINOGEN CALIBRATOR KIT (K994341) | Dade Behring, Inc. | 2000-03-03 |
Recalls involving this device
No recalls on record reference this clearance.