The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Acetaminophen Serum Tox Eia Assay.
Device ID | K961373 |
510k Number | K961373 |
Device Name: | ACETAMINOPHEN SERUM TOX EIA ASSAY |
Classification | Colorimetry, Acetaminophen |
Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
Contact | Yuh-geng Tsay |
Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
Product Code | LDP |
CFR Regulation Number | 862.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-09 |
Decision Date | 1996-07-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884883001176 | K961373 | 000 |
00884883001169 | K961373 | 000 |