Icl Scientific
Mchenry, IL, US
Icl Scientific appears in FDA device records in Mchenry, IL. FDA records list 48 510(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
- 48
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 48 510(k) clearances for Icl Scientific between 1976 and 1988. The busiest year on record is 1978, with 14. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 14 |
| 1979 | 6 |
| 1980 | 1 |
| 1981 | 11 |
| 1982 | 10 |
| 1983 | 2 |
| 1984 | 2 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | JJY | Substantially Equivalent | |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | JJW | Substantially Equivalent | |
| K833761 | THERAPEUTIC DRUG CONTROL | DKB | Substantially Equivalent | |
| K832823 | ENZYMUNE-TEST TSH | JLW | Substantially Equivalent | |
| K831383 | EVENT-TEST SLIDE | JHJ | Substantially Equivalent | |
| K823199 | ENZYME-TEST DIGOXIN | KXT | Substantially Equivalent | |
| K822777 | THERAPEUTIC DRUG CONTROL | DIF | Substantially Equivalent | |
| K822346 | HISTIMUNE ENZYME-ANA TEST | LJM | Substantially Equivalent | |
| K822465 | ENZYMUNE SYSTEM I | JJE | Substantially Equivalent | |
| K821374 | ENZYMUNE-TEST INSULIN | CFP | Substantially Equivalent | |
| K821097 | SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA | Substantially Equivalent | ||
| K821000 | ENZYMUNE-TEST DIGOXIN | DON | Substantially Equivalent | |
| K820879 | ENZYME-TEST TBC T4 UPTAKE | KHQ | Substantially Equivalent | |
| K820763 | ENZYM-LINKED T3 | CDP | Substantially Equivalent | |
| K820750 | ENZYMUNE-TEST T4 | KLI | Substantially Equivalent | |
| K811756 | THERAPEUTIC DRUG CONTROL | DIF | Substantially Equivalent | |
| K811219 | KOVA STRIP 6 | JIR | Substantially Equivalent | |
| K811126 | AIM SYSTEM (FOR IGG) | DEW | Substantially Equivalent | |
| K811125 | AIM SYSTEM (FOR IGA) | CZP | Substantially Equivalent | |
| K811124 | AIM SYSTEM (FOR IGM) | DFT | Substantially Equivalent | |
| K810917 | KOVA TROL I HUMAN URINE (DRIED) | JJW | Substantially Equivalent | |
| K810226 | SLE ANTI-N-DNA LATEX TEST | DHC | Substantially Equivalent | |
| K810056 | IMMUNOLOGY CONTROL SERUM | DEW | Substantially Equivalent | |
| K803274 | AUTOMATED IMMUNOPRECIPITIN METHOD/IGA | CZP | Substantially Equivalent | |
| K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | DFZ | Substantially Equivalent | |
| K803251 | AIP SYSTEM-METHOD FOR IGM | DFT | Substantially Equivalent | |
| K800897 | RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. | DEW | Substantially Equivalent | |
| K792472 | ELECTRO-IMMUNO-QUANTITATION (EIQ) | DAK | Substantially Equivalent | |
| K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN | FAM | Substantially Equivalent | |
| K791824 | ANTISERUM TO HUMAN IMMUNOGLOBULINS | DEW | Substantially Equivalent | |
| K790831 | ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST | GTQ | Substantially Equivalent | |
| K790257 | SYSTEMIC LUPUS | DHC | Substantially Equivalent | |
| K790059 | PROACTIVATOR C3, C4 AND C3 | KTP | Substantially Equivalent | |
| K781408 | RID SYSTEM-(ACP) TEST | DEM | Substantially Equivalent | |
| K781024 | CERUOPLASMIN SERUM ANTI-HUMAN | DDB | Substantially Equivalent | |
| K781023 | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | DEX | Substantially Equivalent | |
| K781022 | ANTI-HUMAN CIQ SERUM | DAK | Substantially Equivalent | |
| K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | DBA | Substantially Equivalent | |
| K781016 | C3PA (GBG) PROPERDIN FACTOR B | JZH | Substantially Equivalent | |
| K781015 | ANTI-HUMAN LDL SERUM | DFC | Substantially Equivalent | |
| K781026 | ANTITHROMBIN III SERUM, ANTI-HUMAN | JBQ | Substantially Equivalent | |
| K781220 | ANTI-HUMAN LAMBDA SERUM | DEH | Substantially Equivalent | |
| K781028 | KAPPA SERUM (FREE & BOUND) ANTI-HUMAN | DFH | Substantially Equivalent | |
| K781027 | KAPPA SERUM (FREE) ANTI-HUMAN | DFH | Substantially Equivalent | |
| K781025 | LAMBDA SERUM (FREE) ANTI-HUMAN | DEH | Substantially Equivalent | |
| K780482 | KOVA TROL III | JJW | Substantially Equivalent | |
| K780325 | RID SYSTEM-HUMAN C-REACTIVE PROTEIN | DEN | Substantially Equivalent | |
| K760354 | TEST, SLIDE FOR C-REATIVE PROTEIN | DCK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JBQAntithrombin Iii Quantitation
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DDBCeruloplasmin, Antigen, Antiserum, Control
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DAKComplement C1q, Antigen, Antiserum, Control
- KTPComplement C3b Activator Immunoassay Reagents
- DIFDrug Mixture Control Materials
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- JZHFactor B, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KHQRadioassay, Triiodothyronine Uptake
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- CFPRadioimmunoassay, Immunoreactive Insulin
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- DHCSystem, Test, Systemic Lupus Erythematosus
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain