The following data is part of a premarket notification filed by Chromatics Color Sciences Intl., Inc. with the FDA for Colormate Iii.
| Device ID | K964590 |
| 510k Number | K964590 |
| Device Name: | COLORMATE III |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | CHROMATICS COLOR SCIENCES INTL., INC. 16809 BRIARDALE RD. Rockville, MD 20855 |
| Contact | Thommas M Tsakeris |
| Correspondent | Thommas M Tsakeris CHROMATICS COLOR SCIENCES INTL., INC. 16809 BRIARDALE RD. Rockville, MD 20855 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-07-24 |
| Summary: | summary |