The following data is part of a premarket notification filed by Acon Laboratories Co. with the FDA for Acon Strep A Rapid Test Strip.
| Device ID | K010582 |
| 510k Number | K010582 |
| Device Name: | ACON STREP A RAPID TEST STRIP |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Robert Hudak |
| Correspondent | Robert Hudak 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 | 2001-02-27 |
| Decision Date | 2001-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066000014 | K010582 | 000 |