The following data is part of a premarket notification filed by Remel Co. with the FDA for A.c.t. Ii.
| Device ID | K965152 |
| 510k Number | K965152 |
| Device Name: | A.C.T. II |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838018282 | K965152 | 000 |
| 00848838018275 | K965152 | 000 |
| 00848838018268 | K965152 | 000 |