DSL DHEA (DSL 8900)
FDA 510(k) clearance K921534 · decided 1992-05-26
Clearance details
- K-number
- K921534
- Device name
- DSL DHEA (DSL 8900)
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-31
- Decision date
- 1992-05-26
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JKL
- Device class
- 1
- Regulation number
- 862.1060
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, 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 |
|---|---|---|
| HEMATOLOGY ANALYZER (K842310) | Hml Inc/Biotechnology Transfer | 1984-09-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determinat recall (Z-2882-2011) | Beckman Coulter Inc. | 2011-07-26 |