510(k) K935629
K935629 is an FDA 510(k) premarket notification submitted by U.S. Drug Testing, Inc. for the device "USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400". The FDA issued a decision of Substantially Equivalent on April 12, 1994. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. U.S. Drug Testing, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1994
- Date Received
- November 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Phencyclidine
- Device Class
- Class U
- Regulation Number
- Review Panel
- TX
- Submission Type