The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Immunoglobulin A Test System.
Device ID | K881827 |
510k Number | K881827 |
Device Name: | IMMUNOGLOBULIN A TEST SYSTEM |
Classification | Radioimmunoassay, Immunoglobulins (g, A, M) |
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 | CFQ |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-29 |
Decision Date | 1988-06-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05051700010450 | K881827 | 000 |