The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Alpha-1-antitrypsin Immunological Nl Test Kit.
Device ID | K913666 |
510k Number | K913666 |
Device Name: | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT |
Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
Applicant | THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
Contact | Jay H Geller |
Correspondent | Jay H Geller THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
Product Code | DEM |
CFR Regulation Number | 866.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-19 |
Decision Date | 1991-12-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05051700010696 | K913666 | 000 |