The following data is part of a premarket notification filed by Pacific Biotech, Inc. with the FDA for Hcg Irma, Cat. No. Cr-1501.
Device ID | K862007 |
510k Number | K862007 |
Device Name: | HCG IRMA, CAT. NO. CR-1501 |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
Contact | Shu-ching Cheng |
Correspondent | Shu-ching Cheng PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-27 |
Decision Date | 1986-07-01 |