The following data is part of a premarket notification filed by Micro Diagnostics Corp. with the FDA for Spuncrit (model Drc-40).
| Device ID | K961803 |
| 510k Number | K961803 |
| Device Name: | SPUNCRIT (MODEL DRC-40) |
| Classification | Centrifuge, Hematocrit |
| Applicant | MICRO DIAGNOSTICS CORP. 170-57 S. COMMERCE WAY Bethlehem, PA 18017 |
| Contact | Rodney A Katzer |
| Correspondent | Rodney A Katzer MICRO DIAGNOSTICS CORP. 170-57 S. COMMERCE WAY Bethlehem, PA 18017 |
| Product Code | GKG |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-07-05 |
| Summary: | summary |