ABBOTT IMX PROLACTIN(MODIFICATION)
FDA 510(k) clearance K953656 · decided 1995-10-03
Clearance details
- K-number
- K953656
- Device name
- ABBOTT IMX PROLACTIN(MODIFICATION)
- Applicant
- Abbott Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-18
- Decision date
- 1995-10-03
- 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
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.