The following data is part of a premarket notification filed by Zymo Research with the FDA for Dna/rna Shield Collection Tube.
| Device ID | K202641 |
| 510k Number | K202641 |
| Device Name: | DNA/RNA Shield Collection Tube |
| Classification | Microbial Nucleic Acid Storage And Stabilization Device |
| Applicant | Zymo Research 17062 Murphy Ave. Irvine, CA 92614 |
| Contact | Julie Ogi |
| Correspondent | Julie Ogi Zymo Research 17062 Murphy Ave. Irvine, CA 92614 |
| Product Code | QBD |
| CFR Regulation Number | 866.2950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2020-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850027600031 | K202641 | 000 |
| 00850027600024 | K202641 | 000 |