The following data is part of a premarket notification filed by Clintech Diagnostics Corp. with the FDA for Acetaminophen Stat-pak Reagent Set.
| Device ID | K821969 |
| 510k Number | K821969 |
| Device Name: | ACETAMINOPHEN STAT-PAK REAGENT SET |
| Classification | Colorimetry, Acetaminophen |
| Applicant | CLINTECH DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-01 |
| Decision Date | 1982-07-16 |