The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Ivc Three Blastocyst Medium, Cat # 2007.
Device ID | K001113 |
510k Number | K001113 |
Device Name: | IVC THREE BLASTOCYST MEDIUM, CAT # 2007 |
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 | 2000-04-06 |
Decision Date | 2000-06-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859268006107 | K001113 | 000 |