The following data is part of a premarket notification filed by Accumed Intl., Inc. with the FDA for Gram Positive Autoidentification Plates, Sensititre Ap90.
| Device ID | K972576 |
| 510k Number | K972576 |
| Device Name: | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 |
| Classification | Gram Positive Identification Panel |
| Applicant | ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K Westlake, OH 44145 |
| Contact | Cindy Knapp |
| Correspondent | Cindy Knapp ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K Westlake, OH 44145 |
| Product Code | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1998-01-22 |