The following data is part of a premarket notification filed by Chimera Research & Chemical, Inc. with the FDA for Tox Perfect B Tubes And Reagents.
Device ID | K952501 |
510k Number | K952501 |
Device Name: | TOX PERFECT B TUBES AND REAGENTS |
Classification | Columns, Liquid Chromatography |
Applicant | CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
Contact | Charles A Hay |
Correspondent | Charles A Hay CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
Product Code | DPM |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-30 |
Decision Date | 1995-08-24 |