DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
FDA 510(k) clearance K960561 · decided 1996-04-26
Clearance details
- K-number
- K960561
- Device name
- DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-09
- Decision date
- 1996-04-26
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- CFT
- Device class
- 1
- Regulation number
- 862.1625
- 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 |
|---|---|---|
| Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Link recall (Z-2047-2011) | Beckman Coulter Inc. | 2011-04-20 |