The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Immunoglobulin M Test System.
| Device ID | K881828 |
| 510k Number | K881828 |
| Device Name: | IMMUNOGLOBULIN M 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 | 1988-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700010467 | K881828 | 000 |