ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
FDA 510(k) clearance K002128 · decided 2000-12-05
Clearance details
- K-number
- K002128
- Device name
- ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-14
- Decision date
- 2000-12-05
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- NDR
- Device class
- 1
- Regulation number
- 862.1260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The Inhib recall (Z-2772-2011) | Beckman Coulter Inc. | 2011-07-11 |
| Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhi recall (Z-2773-2011) | Beckman Coulter Inc. | 2011-07-11 |
| Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The Inhib recall (Z-2774-2011) | Beckman Coulter Inc. | 2011-07-11 |
| Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4 The Inhi recall (Z-2775-2011) | Beckman Coulter Inc. | 2011-07-11 |