ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
FDA 510(k) clearance K911725 · decided 1991-06-03
Clearance details
- K-number
- K911725
- Device name
- ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-17
- Decision date
- 1991-06-03
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.