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 |