Company ยท US
Dade Chemistry Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 1997. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 4 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 |
| JIW | Calibrator, Surrogate | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 1997 | K973650 | TROPONIN (TROP) METHOD Dade Chemistry Systems, Inc. | MMI |
| Sep 29, 1997 | K973100 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
| Sep 29, 1997 | K973099 | PROSTATE SPECIFIC ANTIGEN CONTROL Dade Chemistry Systems, Inc. | JJX |
| Sep 18, 1997 | K973101 | PROSTATE SPECIFIC ANTIGEN METHOD Dade Chemistry Systems, Inc. | LTJ |
| Apr 28, 1997 | K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM Dade Chemistry Systems, Inc. | CEC |
| Mar 10, 1997 | K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD Dade Chemistry Systems, Inc. | DHA |
| Mar 3, 1997 | K970393 | THYROID STIMULATING HORMONE METHOD Dade Chemistry Systems, Inc. | JLW |
| Mar 3, 1997 | K970336 | MMB CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
| Feb 20, 1997 | K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR Dade Chemistry Systems, Inc. | JIW |
| Feb 18, 1997 | K970389 | THYROID CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
| Feb 14, 1997 | K970343 | MMB METHOD Dade Chemistry Systems, Inc. | JHY |
| Jan 24, 1997 | K963498 | FERR FLEX REAGENT CARTRIDGE Dade Chemistry Systems, Inc. | JMG |
| Dec 3, 1996 | K963493 | FERRITIN CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||