MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
FDA 510(k) clearance K900702 · decided 1990-04-12
Clearance details
- K-number
- K900702
- Device name
- MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
- Applicant
- Innotron of Oregon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-12
- Decision date
- 1990-04-12
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LGI
- Device class
- 2
- Regulation number
- 862.3645
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Portland, OR, 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 |
|---|---|---|
| FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (K944063) | Sigma Diagnostics, Inc. | 1994-11-10 |
| AXSYM(TM) QUINIDINE (K940682) | Abbott Laboratories | 1994-06-21 |
Recalls involving this device
No recalls on record reference this clearance.