Seragen Diagnostics, Inc.
Mchenry, IL, US
Seragen Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Seragen Diagnostics, Inc. between 1982 and 1987. The busiest year on record is 1984, with 9. The most recent is 1987, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 9 |
| 1985 | 6 |
| 1987 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K872148 | VIVID CHLAMYDIA(TM) | LJC | Substantially Equivalent | |
| K851663 | QUICK-COUNT HEMATOLOGY CONTROLS | JPK | Substantially Equivalent | |
| K852260 | QUICK-CHEM CALIBRATION SET | JIW | Substantially Equivalent | |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | JJT | Substantially Equivalent | |
| K851521 | LD-1(IMMUNO) SEPARATION SET | CEX | Substantially Equivalent | |
| K850209 | QUICK-LYTE | JGS | Substantially Equivalent | |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | LLL | Substantially Equivalent | |
| K842563 | SERATEST DNA DETERMINATION | LKJ | Substantially Equivalent | |
| K841504 | QUICK-COUNT PLUS 2 | GKL | Substantially Equivalent | |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | JJT | Substantially Equivalent | |
| K840863 | SERATEST RF LATEX DETERMINATION | DHR | Substantially Equivalent | |
| K834396 | DIRECT IRON REAGENT SET | CFM | Substantially Equivalent | |
| K833972 | QUICK-COUNT HEMATOLOGY REAGENT KIT | GIF | Substantially Equivalent | |
| K833971 | QUICK-COUNT | GKL | Substantially Equivalent | |
| K833931 | UREA NITROGEN-UV | CDQ | Substantially Equivalent | |
| K833744 | ALKALINE PHOSPHATASE-RATE | CJE | Substantially Equivalent | |
| K832926 | ENZYMATIC GLUCOSE DETERMINATION | CGA | Substantially Equivalent | |
| K832759 | TOTAL IRON-BINDING CAPACITY ACCESORY | JMO | Substantially Equivalent | |
| K831525 | H-FLU B ELISA TEST | GRP | Substantially Equivalent | |
| K822115 | SERAGAN ACTH125 I-RIA KIT | CKG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LKJAntinuclear Antibody, Antigen, Control
- GRPAntisera, All Types, H. Influenza
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- JIWCalibrator, Surrogate
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes
- GKLCounter, Cell, Automated (Particle Counter)
- GIFDiluent, Blood Cell
- JGSElectrode, Ion Specific, Sodium
- JJTEnzyme Controls (Assayed And Unassayed)
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LLLExtractable Antinuclear Antibody, Antigen And Control
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CGAGlucose Oxidase, Glucose
- JPKMixture, Hematology Quality Control
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CKGRadioimmunoassay, Acth
- DHRSystem, Test, Rheumatoid Factor
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
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 Seragen Diagnostics, 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 Seragen Diagnostics, 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