Dade Chemistry Systems, Inc.
Newark, DE, US
Dade Chemistry Systems, Inc. appears in FDA device records in Newark, DE. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Dade Chemistry Systems, Inc. between 1996 and 1997. The busiest year on record is 1997, with 12. The most recent is 1997, with 12.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 12 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973650 | TROPONIN (TROP) METHOD | MMI | Substantially Equivalent | |
| K973100 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR | JIT | Substantially Equivalent | |
| K973099 | PROSTATE SPECIFIC ANTIGEN CONTROL | JJX | Substantially Equivalent | |
| K973101 | PROSTATE SPECIFIC ANTIGEN METHOD | LTJ | Substantially Equivalent | |
| K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM | CEC | Substantially Equivalent | |
| K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD | DHA | Substantially Equivalent | |
| K970393 | THYROID STIMULATING HORMONE METHOD | JLW | Substantially Equivalent | |
| K970336 | MMB CALIBRATOR | JIT | Substantially Equivalent | |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | JIW | Substantially Equivalent | |
| K970389 | THYROID CALIBRATOR | JIT | Substantially Equivalent | |
| K970343 | MMB METHOD | JHY | Substantially Equivalent | |
| K963498 | FERR FLEX REAGENT CARTRIDGE | JMG | Substantially Equivalent | |
| K963493 | FERRITIN CALIBRATOR | JIT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JITCalibrator, Secondary
- JIWCalibrator, Surrogate
- JHYColorimetric Method, Cpk Or Isoenzymes
- MMIImmunoassay Method, Troponin Subunit
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CECRadioimmunoassay, Free Thyroxine
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Dade Chemistry Systems, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Dade Chemistry Systems, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain