The following data is part of a premarket notification filed by Remel Co. with the FDA for Synergy Quad.
| Device ID | K941443 |
| 510k Number | K941443 |
| Device Name: | SYNERGY QUAD |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary A Silvius |
| Correspondent | Mary A Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838004216 | K941443 | 000 |