The following data is part of a premarket notification filed by Anthos Labtec, Inc. with the FDA for Anthos 2010 Reader.
| Device ID | K955077 |
| 510k Number | K955077 |
| Device Name: | ANTHOS 2010 READER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ANTHOS LABTEC, INC. 67 THOMAS JOHNSON DR., SUITE 22 Frederick, MD 21702 |
| Contact | Norman Jenkins |
| Correspondent | Norman Jenkins ANTHOS LABTEC, INC. 67 THOMAS JOHNSON DR., SUITE 22 Frederick, MD 21702 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1995-12-04 |