The following data is part of a premarket notification filed by Harry A. Schlakman with the FDA for Capitol Urine Drug Screen Collection Kit.
| Device ID | K951122 |
| 510k Number | K951122 |
| Device Name: | CAPITOL URINE DRUG SCREEN COLLECTION KIT |
| Classification | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
| Applicant | HARRY A. SCHLAKMAN 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman HARRY A. SCHLAKMAN 304 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | KDW |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-05-05 |