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 |