The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Lh Quantitative & Qualitative.
Device ID | K863442 |
510k Number | K863442 |
Device Name: | UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
Contact | Joseph Fu |
Correspondent | Joseph Fu UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-05 |
Decision Date | 1987-02-04 |