The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Spq Crp Control Level Ii.
| Device ID | K935075 |
| 510k Number | K935075 |
| Device Name: | SPQ CRP CONTROL LEVEL II |
| Classification | System, Test, C-reactive Protein |
| Applicant | INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Mary E Best |
| Correspondent | Mary E Best INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-01-11 |