The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite(tm) T-uptake.
| Device ID | K910677 |
| 510k Number | K910677 |
| Device Name: | IMMULITE(TM) T-UPTAKE |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| 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 | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-15 |
| Decision Date | 1991-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414978222 | K910677 | 000 |
| 00630414962207 | K910677 | 000 |