The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Acetaminophen Reagent, Model Ref 07989138.
| Device ID | K100200 |
| 510k Number | K100200 |
| Device Name: | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 |
| Classification | Colorimetry, Acetaminophen |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595894 | K100200 | 000 |
| 00630414498942 | K100200 | 000 |