The following data is part of a premarket notification filed by Genchem, Inc. with the FDA for Calibrator 1,2, And 3 Models: Gen-cal1, Gen-cal2, And Gen-cal3.
| Device ID | K090283 |
| 510k Number | K090283 |
| Device Name: | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | GENCHEM, INC. 510 WEST CENTRAL AVE., SUITE D Brea, CA 92821 |
| Contact | James M Henneman |
| Correspondent | James M Henneman GENCHEM, INC. 510 WEST CENTRAL AVE., SUITE D Brea, CA 92821 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007129 | K090283 | 000 |
| 00851445007112 | K090283 | 000 |
| 00851445007105 | K090283 | 000 |