The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Complementc3 (c3) And Complementc4 (c4) Reagent.
| Device ID | K964842 |
| 510k Number | K964842 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-343 Brea, CA 92822 -8000 |
| Contact | Margie George |
| Correspondent | Margie George BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-343 Brea, CA 92822 -8000 |
| Product Code | CZW |
| Subsequent Product Code | DBI |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590230487 | K964842 | 000 |
| 15099590230449 | K964842 | 000 |