The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Nephelometer 100.
| Device ID | K892223 |
| 510k Number | K892223 |
| Device Name: | BEHRING NEPHELOMETER 100 |
| Classification | Nephelometer |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John W Hufhwa |
| Correspondent | John W Hufhwa BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JZW |
| CFR Regulation Number | 866.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-05-04 |