The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, Minipak.
| Device ID | K152679 |
| 510k Number | K152679 |
| Device Name: | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | BIO-RAD LABORATORIES 9500 JERONIMO ROAD Irvine, CA 92614 |
| Contact | Elizabeth Platt |
| Correspondent | Maria Zeballos BIO-RAD LABORATORIES 9500 JERONIMO ROAD Irvine, CA 92614 |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-18 |
| Decision Date | 2016-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520530092 | K152679 | 000 |
| 03610520530085 | K152679 | 000 |
| 03610520530078 | K152679 | 000 |
| 03610520530061 | K152679 | 000 |
| 03610520530054 | K152679 | 000 |