The following data is part of a premarket notification filed by Boston Biomedica, Inc. with the FDA for Accurun 117 Hbeag Positive Control.
| Device ID | K972048 |
| 510k Number | K972048 |
| Device Name: | ACCURUN 117 HBEAG 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 | 1997-06-02 |
| Decision Date | 1997-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816784020291 | K972048 | 000 |