The following data is part of a premarket notification filed by Labone, Inc. with the FDA for Labone Micro-plate Cotinine Eia.
Device ID | K033601 |
510k Number | K033601 |
Device Name: | LABONE MICRO-PLATE COTININE EIA |
Classification | Calibrators, Drug Specific |
Applicant | LABONE, INC. 10101 RENNER BLVD. Lenexa, KS 66219 |
Contact | Liuming Yu |
Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | DLJ |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-11-14 |
Decision Date | 2004-02-10 |
Summary: | summary |