The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Calibrators.
| Device ID | K003096 |
| 510k Number | K003096 |
| Device Name: | FASTPACK CALIBRATORS |
| Classification | Calibrator, Secondary |
| Applicant | Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 |
| Contact | Dorothy Deinzer |
| Correspondent | Dorothy Deinzer Qualigen, Inc. 2042 CORTE DEL NOGAL Carlsbad, CA 92009 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816467020020 | K003096 | 000 |