The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite (tm) Total T3.
| Device ID | K905214 |
| 510k Number | K905214 |
| Device Name: | IMMULITE (TM) TOTAL T3 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Contact | Robert Fennell |
| Correspondent | Robert Fennell CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414970103 | K905214 | 000 |
| 00630414968599 | K905214 | 000 |
| 00630414966021 | K905214 | 000 |
| 00630414954363 | K905214 | 000 |