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 |