Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
FDA 510(k) K152679 · Bio-Rad Laboratories
510(k) numberK152679
Submission
- Device name
- Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
- Applicant
- Bio-Rad Laboratories
Irvine, CA, US - Received
- September 18, 2015
- Decision date
- May 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3920
- Specialty
- Microbiology
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
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Questions and answers
When was Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak cleared by the FDA?
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak (K152679) received a 510(k) decision of Substantially Equivalent on May 10, 2016, 235 days after the submission was received.
What is the product code of K152679?
The FDA product code is PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.