The following data is part of a premarket notification filed by Dade Microscan, Inc. with the FDA for Microscan Rapid Gram-negative Indentification Type 3 Panel.
| Device ID | K961042 |
| 510k Number | K961042 |
| Device Name: | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL |
| Classification | Instrument For Auto Reader Of Overnight Microorganism Identification System |
| Applicant | DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Sharolyn J Lentsch |
| Correspondent | Sharolyn J Lentsch DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-14 |
| Decision Date | 1996-05-30 |
| Summary: | summary |