The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Na Latex Myoglobin Test.
| Device ID | K902154 |
| 510k Number | K902154 |
| Device Name: | NA LATEX MYOGLOBIN TEST |
| Classification | Myoglobin, 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 | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012808 | K902154 | 000 |
| 00630414285047 | K902154 | 000 |