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 |