The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Human Serum Albumin (hsa).
Device ID | K000940 |
510k Number | K000940 |
Device Name: | HUMAN SERUM ALBUMIN (HSA) |
Classification | Media, Reproductive |
Applicant | INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego, CA 92121 |
Contact | Robert E Lovins |
Correspondent | Robert E Lovins INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego, CA 92121 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-23 |
Decision Date | 2000-05-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859268006114 | K000940 | 000 |