The following data is part of a premarket notification filed by Acon Laboratories Co. with the FDA for Acon Strep A Twist Test Device.
| Device ID | K023766 |
| 510k Number | K023766 |
| Device Name: | ACON STREP A TWIST TEST DEVICE |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2003-02-10 |
| Summary: | summary |