The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Complement Activation Eia Test System (cae).
Device ID | K951639 |
510k Number | K951639 |
Device Name: | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) |
Classification | Complement C9, Antigen, Antiserum, Control |
Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Contact | Mary E Best |
Correspondent | Mary E Best INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Product Code | DAE |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-10 |
Decision Date | 1995-10-13 |