The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite(tm) Total T4.
| Device ID | K910261 |
| 510k Number | K910261 |
| Device Name: | IMMULITE(TM) TOTAL T4 |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| 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 | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414972992 | K910261 | 000 |
| 00630414970110 | K910261 | 000 |
| 00630414966229 | K910261 | 000 |
| 00630414966038 | K910261 | 000 |
| 00630414954370 | K910261 | 000 |