Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Icl Scientific — Predicate Candidate Screening

48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

28 daysmedian FDA review time
59 days90th percentile
48clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLIcl Scientific1988-11-10520
K843565KOVA TROL I,II, III HUMAN URINE-DRIEDIcl Scientific1984-10-05250
K833761THERAPEUTIC DRUG CONTROLIcl Scientific1984-01-13790
K832823ENZYMUNE-TEST TSHIcl Scientific1983-10-14560
K831383EVENT-TEST SLIDEIcl Scientific1983-06-22550
K823199ENZYME-TEST DIGOXINIcl Scientific1982-11-29340
K822346HISTIMUNE ENZYME-ANA TESTIcl Scientific1982-10-08630
K822777THERAPEUTIC DRUG CONTROLIcl Scientific1982-10-08240
K822465ENZYMUNE SYSTEM IIcl Scientific1982-09-14290
K821374ENZYMUNE-TEST INSULINIcl Scientific1982-05-28180
K821097SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNAIcl Scientific1982-05-05150
K821000ENZYMUNE-TEST DIGOXINIcl Scientific1982-04-26180
K820879ENZYME-TEST TBC T4 UPTAKEIcl Scientific1982-04-16170
K820763ENZYM-LINKED T3Icl Scientific1982-04-15240
K820750ENZYMUNE-TEST T4Icl Scientific1982-04-06180
K811756THERAPEUTIC DRUG CONTROLIcl Scientific1981-07-15230
K811219KOVA STRIP 6Icl Scientific1981-05-21170
K811126AIM SYSTEM (FOR IGG)Icl Scientific1981-05-08140
K811124AIM SYSTEM (FOR IGM)Icl Scientific1981-05-08140
K811125AIM SYSTEM (FOR IGA)Icl Scientific1981-05-08140
K810917KOVA TROL I HUMAN URINE (DRIED)Icl Scientific1981-04-1480
K810226SLE ANTI-N-DNA LATEX TESTIcl Scientific1981-02-09130
K810056IMMUNOLOGY CONTROL SERUMIcl Scientific1981-02-09270
K803274AUTOMATED IMMUNOPRECIPITIN METHOD/IGAIcl Scientific1981-01-26280
K803272AUTOMATED IMMUNOPRECIPITIN METHOD/ICGIcl Scientific1981-01-26280
K803251AIP SYSTEM-METHOD FOR IGMIcl Scientific1981-01-26340
K800897RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.Icl Scientific1980-05-08200
K792472ELECTRO-IMMUNO-QUANTITATION (EIQ)Icl Scientific1979-12-27240
K792314RID SYSTEMS - ALPH-1-ACID GLYCOPROTEINIcl Scientific1979-12-06200
K791824ANTISERUM TO HUMAN IMMUNOGLOBULINSIcl Scientific1979-10-17330
K790831ANTISTREPTOLYSIN (ASO) LATEX SLIDE TESTIcl Scientific1979-06-15460
K790257SYSTEMIC LUPUSIcl Scientific1979-03-15370
K790059PROACTIVATOR C3, C4 AND C3Icl Scientific1979-03-15650
K781408RID SYSTEM-(ACP) TESTIcl Scientific1978-08-2170
K781017ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)Icl Scientific1978-08-14590
K781022ANTI-HUMAN CIQ SERUMIcl Scientific1978-08-14560
K781015ANTI-HUMAN LDL SERUMIcl Scientific1978-08-14590
K781016C3PA (GBG) PROPERDIN FACTOR BIcl Scientific1978-08-14590
K781023ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HUIcl Scientific1978-08-14560
K781024CERUOPLASMIN SERUM ANTI-HUMANIcl Scientific1978-08-14560
K781026ANTITHROMBIN III SERUM, ANTI-HUMANIcl Scientific1978-08-10520
K781027KAPPA SERUM (FREE) ANTI-HUMANIcl Scientific1978-07-27380
K781028KAPPA SERUM (FREE & BOUND) ANTI-HUMANIcl Scientific1978-07-27380
K781025LAMBDA SERUM (FREE) ANTI-HUMANIcl Scientific1978-07-27380
K781220ANTI-HUMAN LAMBDA SERUMIcl Scientific1978-07-27100
K780482KOVA TROL IIIIcl Scientific1978-05-03370
K780325RID SYSTEM-HUMAN C-REACTIVE PROTEINIcl Scientific1978-03-17180
K760354TEST, SLIDE FOR C-REATIVE PROTEINIcl Scientific1976-08-1190

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda