The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quikpac Ii Onestep Strep A Immunochromatographic Assay.
| Device ID | K935554 |
| 510k Number | K935554 |
| Device Name: | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST Carlsbad, CA 92008 |
| Contact | James P Lee, Ph.d. |
| Correspondent | James P Lee, Ph.d. SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST Carlsbad, CA 92008 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1995-08-30 |