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

Seragen Diagnostics, Inc. — Predicate Candidate Screening

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

70 daysmedian FDA review time
115 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872148VIVID CHLAMYDIA(TM)Seragen Diagnostics, Inc.1987-08-19760
K851663QUICK-COUNT HEMATOLOGY CONTROLSSeragen Diagnostics, Inc.1985-07-23910
K852260QUICK-CHEM CALIBRATION SETSeragen Diagnostics, Inc.1985-07-22590
K851520CK/LD ISOENZYMES CONTROLS(HUMAN)Seragen Diagnostics, Inc.1985-06-25710
K851521LD-1(IMMUNO) SEPARATION SETSeragen Diagnostics, Inc.1985-05-10250
K850209QUICK-LYTESeragen Diagnostics, Inc.1985-02-27400
K844743SERATEST ENA(RNP/SM) DETERMINATIONSeragen Diagnostics, Inc.1985-02-04610
K842563SERATEST DNA DETERMINATIONSeragen Diagnostics, Inc.1984-10-251150
K841504QUICK-COUNT PLUS 2Seragen Diagnostics, Inc.1984-06-11620
K840793CK/MB IMMUNO-ISOENZYME CONTROL SERUMSeragen Diagnostics, Inc.1984-04-13500
K840863SERATEST RF LATEX DETERMINATIONSeragen Diagnostics, Inc.1984-04-04400
K834396DIRECT IRON REAGENT SETSeragen Diagnostics, Inc.1984-02-21690
K833972QUICK-COUNT HEMATOLOGY REAGENT KITSeragen Diagnostics, Inc.1984-02-17930
K833971QUICK-COUNTSeragen Diagnostics, Inc.1984-01-30750
K833744ALKALINE PHOSPHATASE-RATESeragen Diagnostics, Inc.1984-01-13790
K833931UREA NITROGEN-UVSeragen Diagnostics, Inc.1984-01-13600
K832926ENZYMATIC GLUCOSE DETERMINATIONSeragen Diagnostics, Inc.1983-10-28700
K832759TOTAL IRON-BINDING CAPACITY ACCESORYSeragen Diagnostics, Inc.1983-10-14560
K831525H-FLU B ELISA TESTSeragen Diagnostics, Inc.1983-09-291400
K822115SERAGAN ACTH125 I-RIA KITSeragen Diagnostics, Inc.1982-10-18910

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