The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Mononucleosis Rapid Test Strip (whole Blood/serum/plasma).
| Device ID | K042272 |
| 510k Number | K042272 |
| Device Name: | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung, Ph.d. |
| Correspondent | Edward Tung, Ph.d. ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-23 |
| Decision Date | 2005-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066000311 | K042272 | 000 |