The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-e Ige Ii Calibration Verification Set.
| Device ID | K922754 |
| 510k Number | K922754 |
| Device Name: | TANDEM-E IGE II CALIBRATION VERIFICATION SET |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | HYBRITECH, INC. P.O. BOX 269006 San Diego, CA 92196 |
| Contact | Eugene V Goorchenko |
| Correspondent | Eugene V Goorchenko HYBRITECH, INC. P.O. BOX 269006 San Diego, CA 92196 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1993-02-17 |