Diazyme 1,5-AG Assay
FDA 510(k) clearance K180209 · decided 2018-10-04
Clearance details
- K-number
- K180209
- Device name
- Diazyme 1,5-AG Assay
- Applicant
- Diazyme Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-24
- Decision date
- 2018-10-04
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- NOZ
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Poway, CA, 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 |
|---|---|---|
| GLYCOMARK (K031604) | Tomen America, Inc. | 2003-09-22 |
Recalls involving this device
No recalls on record reference this clearance.