The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Genx Culture Dish.
| Device ID | K993881 |
| 510k Number | K993881 |
| Device Name: | GENX CULTURE DISH |
| Classification | Labware, Assisted Reproduction |
| Applicant | INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-16 |
| Decision Date | 2000-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965021812 | K993881 | 000 |
| 00815965021805 | K993881 | 000 |