The following data is part of a premarket notification filed by Boston Biomedica, Inc. with the FDA for Accurun 119 Anti-hepatitis B E Antigen (anti-hbe) Positive Control.
Device ID | K972307 |
510k Number | K972307 |
Device Name: | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater, MA 02379 |
Contact | Patricia E Garrett |
Correspondent | Patricia E Garrett BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater, MA 02379 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-19 |
Decision Date | 1997-08-07 |