The following data is part of a premarket notification filed by Collaborative Research, Inc. with the FDA for Serum Complement Activity Test-scat.
| Device ID | K841541 |
| 510k Number | K841541 |
| Device Name: | SERUM COMPLEMENT ACTIVITY TEST-SCAT |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | COLLABORATIVE RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-16 |
| Decision Date | 1984-06-01 |