The following data is part of a premarket notification filed by Nanogen, Inc. with the FDA for Real-time Pcr Internal Control 2b Set.
| Device ID | K083430 |
| 510k Number | K083430 |
| Device Name: | REAL-TIME PCR INTERNAL CONTROL 2B SET |
| Classification | Internal Polymerase Chain Reaction Control, Not Assay Specific |
| Applicant | NANOGEN, INC. 10398 PACIFIC CENTER CT. San Diego, CA 92121 -4340 |
| Contact | E. Joseph Mcmullen |
| Correspondent | E. Joseph Mcmullen NANOGEN, INC. 10398 PACIFIC CENTER CT. San Diego, CA 92121 -4340 |
| Product Code | OLD |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540951602 | K083430 | 000 |
| 03661540951428 | K083430 | 000 |