The following data is part of a premarket notification filed by Dade Chemistry Systems, Inc. with the FDA for Ft4 Method For The Dimension Rxl Clinical Chemistry System.
| Device ID | K971141 |
| 510k Number | K971141 |
| Device Name: | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | DADE CHEMISTRY SYSTEMS, INC. P.O. BOX 6101, GLASGOW BLDG. 500 MAILBOX 514 Newark, DE 19714 -6101 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DADE CHEMISTRY SYSTEMS, INC. P.O. BOX 6101, GLASGOW BLDG. 500 MAILBOX 514 Newark, DE 19714 -6101 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-28 |
| Decision Date | 1997-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013799 | K971141 | 000 |