The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Haemophilus/streptococcus Pneumoniae (hp) Mic Plate.
Device ID | K012151 |
510k Number | K012151 |
Device Name: | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
Classification | Manual Antimicrobial Susceptibility Test Systems |
Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD. SUITE 1-K Westlake, OH 44145 |
Contact | Cynthia C Knapp |
Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD. SUITE 1-K Westlake, OH 44145 |
Product Code | JWY |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-10 |
Decision Date | 2001-08-29 |