The following data is part of a premarket notification filed by Worthington Biochemical Corp. with the FDA for Uric Acid Std. For Quant. Uric Acid.
Device ID | K772025 |
510k Number | K772025 |
Device Name: | URIC ACID STD. FOR QUANT. URIC ACID |
Classification | Calibrator, Primary |
Applicant | WORTHINGTON BIOCHEMICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIS |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-27 |
Decision Date | 1977-11-11 |