The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Architect T-uptake Calibrators (a-f) And Controls (low, High).
| Device ID | K042307 |
| 510k Number | K042307 |
| Device Name: | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) |
| Classification | Calibrator, Secondary |
| Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-25 |
| Decision Date | 2004-11-03 |