FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
FDA 510(k) clearance K944063 · decided 1994-11-10
Clearance details
- K-number
- K944063
- Device name
- FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-19
- Decision date
- 1994-11-10
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LGI
- Device class
- 2
- Regulation number
- 862.3645
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| AXSYM(TM) QUINIDINE (K940682) | Abbott Laboratories | 1994-06-21 |
| MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (K900702) | Innotron of Oregon, Inc. | 1990-04-12 |
Recalls involving this device
No recalls on record reference this clearance.