The following data is part of a premarket notification filed by Leica, Inc. with the FDA for Unistat Bilirubinometer Models 10310 And 10311.
| Device ID | K922770 |
| 510k Number | K922770 |
| Device Name: | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | LEICA, INC. 203 EGGERT RD. Buffalo, NY 14215 |
| Contact | John Crocker |
| Correspondent | John Crocker LEICA, INC. 203 EGGERT RD. Buffalo, NY 14215 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1992-08-18 |