The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Pvp-polyvinylpyrrolidone Reagent, Model Cat#2210.
Device ID | K001967 |
510k Number | K001967 |
Device Name: | PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 |
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 | 2000-06-28 |
Decision Date | 2000-08-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859268006138 | K001967 | 000 |