The following data is part of a premarket notification filed by Pfizer Pharmaceuticals with the FDA for E-vac Blood Culture System.
Device ID | K802408 |
510k Number | K802408 |
Device Name: | E-VAC BLOOD CULTURE SYSTEM |
Classification | Culture Media, General Nutrient Broth |
Applicant | PFIZER PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSC |
CFR Regulation Number | 866.2350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-03 |
Decision Date | 1980-10-23 |