The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Acetaminophen (enzymatic Rate), Number 502-13.
| Device ID | K885097 |
| 510k Number | K885097 |
| Device Name: | ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 |
| Classification | Colorimetry, Acetaminophen |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | Paula Roth-gregoire |
| Correspondent | Paula Roth-gregoire DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-09 |
| Decision Date | 1989-01-11 |