Submission Details
| 510(k) Number | K042272 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 2004 |
| Decision Date | February 28, 2005 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
Feb 2005
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K042272 is an FDA 510(k) clearance for the ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA), a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 28, 2005, 189 days after receiving the submission on August 23, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.
Device Classification
| Product Code | KTN — System, Test, Infectious Mononucleosis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5640 |
Manufacturer
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