ACTIVE INTACT PTH ELISA
FDA 510(k) clearance K952199 · decided 1995-07-17
Clearance details
- K-number
- K952199
- Device name
- ACTIVE INTACT PTH ELISA
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-10
- Decision date
- 1995-07-17
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- 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 I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked I recall (Z-0584-2011) | Beckman Coulter Inc. | 2010-12-09 |
| Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10 recall (Z-0107-2011) | Beckman Coulter Inc. | 2010-10-20 |