The following data is part of a premarket notification filed by Spectrx, Inc. with the FDA for Bilichek Non-invasive Bilirubin Analyzer.
| Device ID | K994438 |
| 510k Number | K994438 |
| Device Name: | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | SPECTRX, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | James R Veale |
| Correspondent | James R Veale SPECTRX, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-30 |
| Decision Date | 2000-02-04 |
| Summary: | summary |