The following data is part of a premarket notification filed by More Diagnostics with the FDA for Serum Bilirubin Control- Level 1, 2 And 3.
| Device ID | K944999 |
| 510k Number | K944999 |
| Device Name: | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MORE DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Contact | James W Snipes |
| Correspondent | James W Snipes MORE DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-13 |
| Decision Date | 1995-06-06 |