The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Nephelometer System.
| Device ID | K860894 |
| 510k Number | K860894 |
| Device Name: | BEHRING NEPHELOMETER SYSTEM |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-10 |
| Decision Date | 1986-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768030239 | K860894 | 000 |
| 00842768009686 | K860894 | 000 |
| 00842768009853 | K860894 | 000 |
| 00842768009860 | K860894 | 000 |
| 00842768009877 | K860894 | 000 |
| 00842768009884 | K860894 | 000 |
| 00842768009914 | K860894 | 000 |
| 00842768009945 | K860894 | 000 |
| 00842768009952 | K860894 | 000 |
| 00842768011252 | K860894 | 000 |
| 00842768011269 | K860894 | 000 |
| 00842768011436 | K860894 | 000 |
| 00842768011443 | K860894 | 000 |
| 00842768014246 | K860894 | 000 |
| 00842768009679 | K860894 | 000 |