Company ยท US
Icl Scientific
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1988. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | 4 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 3 |
| CZP | Iga, Antigen, Antiserum, Control | 2 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 |
| DEH | Lambda, Antigen, Antiserum, Control | 2 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 |
| DFT | Igm, Antigen, Antiserum, Control | 2 |
| DHC | System, Test, Systemic Lupus Erythematosus | 2 |
| DIF | Drug Mixture Control Materials | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DEN | Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control | 1 |
| DEX | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 10, 1988 | K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL Icl Scientific | JJY |
| Oct 5, 1984 | K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED Icl Scientific | JJW |
| Jan 13, 1984 | K833761 | THERAPEUTIC DRUG CONTROL Icl Scientific | DKB |
| Oct 14, 1983 | K832823 | ENZYMUNE-TEST TSH Icl Scientific | JLW |
| Jun 22, 1983 | K831383 | EVENT-TEST SLIDE Icl Scientific | JHJ |
| Nov 29, 1982 | K823199 | ENZYME-TEST DIGOXIN Icl Scientific | KXT |
| Oct 8, 1982 | K822777 | THERAPEUTIC DRUG CONTROL Icl Scientific | DIF |
| Oct 8, 1982 | K822346 | HISTIMUNE ENZYME-ANA TEST Icl Scientific | LJM |
| Sep 14, 1982 | K822465 | ENZYMUNE SYSTEM I Icl Scientific | JJE |
| May 28, 1982 | K821374 | ENZYMUNE-TEST INSULIN Icl Scientific | CFP |
| May 5, 1982 | K821097 | SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA Icl Scientific | |
| Apr 26, 1982 | K821000 | ENZYMUNE-TEST DIGOXIN Icl Scientific | DON |
| Apr 16, 1982 | K820879 | ENZYME-TEST TBC T4 UPTAKE Icl Scientific | KHQ |
| Apr 15, 1982 | K820763 | ENZYM-LINKED T3 Icl Scientific | CDP |
| Apr 6, 1982 | K820750 | ENZYMUNE-TEST T4 Icl Scientific | KLI |
| Jul 15, 1981 | K811756 | THERAPEUTIC DRUG CONTROL Icl Scientific | DIF |
| May 21, 1981 | K811219 | KOVA STRIP 6 Icl Scientific | JIR |
| May 8, 1981 | K811126 | AIM SYSTEM (FOR IGG) Icl Scientific | DEW |
| May 8, 1981 | K811125 | AIM SYSTEM (FOR IGA) Icl Scientific | CZP |
| May 8, 1981 | K811124 | AIM SYSTEM (FOR IGM) Icl Scientific | DFT |
| Apr 14, 1981 | K810917 | KOVA TROL I HUMAN URINE (DRIED) Icl Scientific | JJW |
| Feb 9, 1981 | K810226 | SLE ANTI-N-DNA LATEX TEST Icl Scientific | DHC |
| Feb 9, 1981 | K810056 | IMMUNOLOGY CONTROL SERUM Icl Scientific | DEW |
| Jan 26, 1981 | K803274 | AUTOMATED IMMUNOPRECIPITIN METHOD/IGA Icl Scientific | CZP |
| Jan 26, 1981 | K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG Icl Scientific | DFZ |
| Jan 26, 1981 | K803251 | AIP SYSTEM-METHOD FOR IGM Icl Scientific | DFT |
| May 8, 1980 | K800897 | RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. Icl Scientific | DEW |
| Dec 27, 1979 | K792472 | ELECTRO-IMMUNO-QUANTITATION (EIQ) Icl Scientific | DAK |
| Dec 6, 1979 | K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN Icl Scientific | FAM |
| Oct 17, 1979 | K791824 | ANTISERUM TO HUMAN IMMUNOGLOBULINS Icl Scientific | DEW |
| Jun 15, 1979 | K790831 | ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST Icl Scientific | GTQ |
| Mar 15, 1979 | K790257 | SYSTEMIC LUPUS Icl Scientific | DHC |
| Mar 15, 1979 | K790059 | PROACTIVATOR C3, C4 AND C3 Icl Scientific | KTP |
| Aug 21, 1978 | K781408 | RID SYSTEM-(ACP) TEST Icl Scientific | DEM |
| Aug 14, 1978 | K781024 | CERUOPLASMIN SERUM ANTI-HUMAN Icl Scientific | DDB |
| Aug 14, 1978 | K781023 | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU Icl Scientific | DEX |
| Aug 14, 1978 | K781022 | ANTI-HUMAN CIQ SERUM Icl Scientific | DAK |
| Aug 14, 1978 | K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) Icl Scientific | DBA |
| Aug 14, 1978 | K781016 | C3PA (GBG) PROPERDIN FACTOR B Icl Scientific | JZH |
| Aug 14, 1978 | K781015 | ANTI-HUMAN LDL SERUM Icl Scientific | DFC |
| Aug 10, 1978 | K781026 | ANTITHROMBIN III SERUM, ANTI-HUMAN Icl Scientific | JBQ |
| Jul 27, 1978 | K781220 | ANTI-HUMAN LAMBDA SERUM Icl Scientific | DEH |
| Jul 27, 1978 | K781028 | KAPPA SERUM (FREE & BOUND) ANTI-HUMAN Icl Scientific | DFH |
| Jul 27, 1978 | K781027 | KAPPA SERUM (FREE) ANTI-HUMAN Icl Scientific | DFH |
| Jul 27, 1978 | K781025 | LAMBDA SERUM (FREE) ANTI-HUMAN Icl Scientific | DEH |
| May 3, 1978 | K780482 | KOVA TROL III Icl Scientific | JJW |
| Mar 17, 1978 | K780325 | RID SYSTEM-HUMAN C-REACTIVE PROTEIN Icl Scientific | DEN |
| Aug 11, 1976 | K760354 | TEST, SLIDE FOR C-REATIVE PROTEIN Icl Scientific | DCK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||