The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Microscan Dri Gram Posit/gram Nega Mic/combo Panel.
| Device ID | K922482 |
| 510k Number | K922482 |
| Device Name: | MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | BAXTER DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Sharon K Cullen |
| Correspondent | Sharon K Cullen BAXTER DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1993-03-12 |