510(k) K951122
K951122 is an FDA 510(k) premarket notification submitted by Harry A. Schlakman for the device "CAPITOL URINE DRUG SCREEN COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on May 5, 1995. The device falls under product code KDW (Container, Specimen Mailer And Storage, Temperature Controlled, Sterile), a Class I device regulated under 21 CFR 864.3250. Harry A. Schlakman has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1995
- Date Received
- February 27, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
- Device Class
- Class I
- Regulation Number
- 864.3250
- Review Panel
- PA
- Submission Type