The following data is part of a premarket notification filed by Iquum Inc with the FDA for Liat Strep A Assay.
| Device ID | K141338 |
| 510k Number | K141338 |
| Device Name: | LIAT STREP A ASSAY |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Applicant | IQUUM INC 700 NICKERSON ROAD Marlborough, MA 01762 -4663 |
| Contact | Lingjun Chen |
| Correspondent | Lingjun Chen IQUUM INC 700 NICKERSON ROAD Marlborough, MA 01762 -4663 |
| Product Code | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-11-04 |
| Summary: | summary |