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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Electrophoresis Corp. of America · Predicate Candidate Screening

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

38 daysmedian FDA review time
55 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802396GENERAL PROCEDURE AGAROSE FILMElectrophoresis Corp. of America1980-11-26550
K792547AGAROSE BARBITAL BUFFERElectrophoresis Corp. of America1980-01-29500
K792548ALKALINE PHOSPHATASE MARKERElectrophoresis Corp. of America1980-01-29500
K792551ALKALINE PHOSPHATASE REAGENTElectrophoresis Corp. of America1980-01-29500
K792553AGAROSE BARBITAL-EDTA BUFFERElectrophoresis Corp. of America1980-01-29500
K792574MOPSO BUFFERElectrophoresis Corp. of America1980-01-21390
K792550PONCEAU S STAIN SETElectrophoresis Corp. of America1980-01-16370
K792549FAT RED 7B STAIN SETElectrophoresis Corp. of America1979-12-1880
K792552AMIDO BLACK 10B STAINElectrophoresis Corp. of America1979-12-1880
K791654NORMAL CONTROLElectrophoresis Corp. of America1979-09-17270
K791655CPK ISOENZYME REAGENTElectrophoresis Corp. of America1979-09-17270
K791656ENZYME STABILIZING REAGENT (ESR)Electrophoresis Corp. of America1979-09-17270
K791657LDH ISOENZYME REAGENTElectrophoresis Corp. of America1979-09-17270
K791299CPK ISOENZYME CONTROLElectrophoresis Corp. of America1979-08-16310
K791300LDH ISOENZYME CONTROLElectrophoresis Corp. of America1979-08-16310
K791008ECA (SPECIAL) HEME BUFFERElectrophoresis Corp. of America1979-08-03640
K781898CLEARING SOLUTION #ECA01976Electrophoresis Corp. of America1978-12-20370
K781122LIPOPROTEIN STAINElectrophoresis Corp. of America1978-08-31590
K781119ECA HEME BUFFERElectrophoresis Corp. of America1978-08-14420
K781121HEMOLYSEElectrophoresis Corp. of America1978-08-14420
K781116ECA BUFFER, PH 816Electrophoresis Corp. of America1978-08-10380
K781117ECA PREPElectrophoresis Corp. of America1978-08-10380
K781118ECA BUFFER PH 8.8Electrophoresis Corp. of America1978-08-10380
K781120TRICHLORACETIC ACID 7.5%Electrophoresis Corp. of America1978-08-10380
K781123PONCEAU SElectrophoresis Corp. of America1978-08-10380
K781124CPK ISOENZYME REAGENTElectrophoresis Corp. of America1978-08-10380
K781125LDH ISOENZYME REAGENTElectrophoresis Corp. of America1978-08-10380

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