The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N-immunoglobulin Light Chain Kit.
| Device ID | K880341 |
| 510k Number | K880341 |
| Device Name: | N-IMMUNOGLOBULIN LIGHT CHAIN KIT |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012709 | K880341 | 000 |
| 00842768012686 | K880341 | 000 |