The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Antithrombin Iii (at3) Reagent.
| Device ID | K974110 |
| 510k Number | K974110 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT |
| Classification | Antithrombin Iii Quantitation |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1997-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590224028 | K974110 | 000 |