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 |