The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit Tox Acetaminophen Assay, Model 7a319ul; Emit Tox Ecetaminophen Calibrators, Model 7a409ul.
| Device ID | K002974 |
| 510k Number | K002974 |
| Device Name: | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL |
| Classification | Colorimetry, Acetaminophen |
| Applicant | DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-17 |
| Decision Date | 2000-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023330 | K002974 | 000 |
| 00842768001567 | K002974 | 000 |
| 00842768001550 | K002974 | 000 |