The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Nutrient Gelatin - Product Number T2860.
Device ID | K880946 |
510k Number | K880946 |
Device Name: | NUTRIENT GELATIN - PRODUCT NUMBER T2860 |
Classification | Culture Media, Single Biochemical Test |
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 | JSF |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-07 |
Decision Date | 1988-04-01 |