The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for P3700 Col. Cna W/5% Sb.
Device ID | K870342 |
510k Number | K870342 |
Device Name: | P3700 COL. CNA W/5% SB |
Classification | Culture Media, Selective And Non-differential |
Applicant | LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas, TX 75207 |
Contact | John E Pedigo |
Correspondent | John E Pedigo LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas, TX 75207 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-28 |
Decision Date | 1987-02-13 |