SEROTONIN ENZYME IMMUNOASSAY
FDA 510(k) clearance K903609 · decided 1990-10-22
Clearance details
- K-number
- K903609
- Device name
- SEROTONIN ENZYME IMMUNOASSAY
- Applicant
- Immunotech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-09
- Decision date
- 1990-10-22
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- CDA
- Device class
- 1
- Regulation number
- 862.1390
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cedex 9 (France), FR
- 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 |
|---|---|---|
| BIO-RAD URINARY 5-HIAA BY HPLC (K952817) | Bio-Rad | 1995-08-01 |
| TDXR 5-HIAA (URINE) (K854946) | Abbott Laboratories | 1986-01-17 |
Recalls involving this device
No recalls on record reference this clearance.