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 |