Tosoh Bioscience, Inc. · Class II · Cleared Jun 15, 2012
| K-number | K121533 |
| Device name | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET |
| Applicant | Tosoh Bioscience, Inc. |
| Product code | LPS |
| Device class | Class II |
| Decision date | Jun 15, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1377 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov