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

Synermed, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time
128 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITSynermed, Inc.1997-09-25370
K972716SYNERMED TOTAL BILIRUBIN REAGENT KITSynermed, Inc.1997-08-07170
K971491SYNERMED IR 200 CHEMISTRY ANALYZERSynermed, Inc.1997-06-26630
K962479SYNERMED ISE REAGENTSSynermed, Inc.1997-03-032500
K963939SYNERMED DIRECT BILIRUBIN REAGENT KITSynermed, Inc.1996-12-18780
K960793SYNERMED ENZYMATIC CO2 REAGENT KITSynermed, Inc.1996-03-11130
K953395SYNERMED CALCIUM REAGENT KITSynermed, Inc.1995-08-31440
K952179SYNERMED ISE REAGENTSSynermed, Inc.1995-06-20420
K943924CREATININE-PO REAGENT KITSynermed, Inc.1994-09-20390
K941091SYNERMED AMYLASE REAGENT KITSynermed, Inc.1994-05-03560
K941400SYNERMED ISE REAGENTSSynermed, Inc.1994-04-26350
K935662SYNERMED IR 500 CHEMISTRY ANALYZERSynermed, Inc.1994-04-261510
K940571SYNERMEDIR CAL I AND SYNERMED IR CAL IISynermed, Inc.1994-04-21720
K940570SYNERMED TOTAL BILIRUBIN REAGENT KITSynermed, Inc.1994-04-20710
K940194SYNERMED ISE REAGENTSSynermed, Inc.1994-04-05820
K933026SYNERMED DIRECT BILIRUBIN REAGENT KITSynermed, Inc.1993-10-281280
K931986AMP ALKALINE PHOSPHATASE REAGENT KITSynermed, Inc.1993-09-081390
K931958SYNERMED GGT REAGENT KITSynermed, Inc.1993-09-081410
K930932SYNERMED CREATINE KINASE REAGENT KITSynermed, Inc.1993-05-11770
K926511SYNERMED SINGLE REAGENT CREATININE KITSynermed, Inc.1993-02-18500
K924428SYNERMED ENZYMATIC CO2 REAGENT KITSynermed, Inc.1992-12-03930
K924427SYNERMED HDL CHOLESTLEROL REAGENT KITSynermed, Inc.1992-11-09690
K923414SYNERMED 600 NM URIC ACID REAGENT KITSynermed, Inc.1992-09-22740
K922784SYNERMED UIBC REAGENT KITSynermed, Inc.1992-07-21420
K921016SYNERMED ALT/GPT REAGENT KITSynermed, Inc.1992-05-07650
K921025SYNERMED LDHH-L REAGENT KITSynermed, Inc.1992-03-23200
K915555SYNERMED AST/GOT REAGENT KITSynermed, Inc.1992-01-27470
K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.1991-07-30270
K912569SYNERMED PHOSPHORUS REAGENT KITSynermed, Inc.1991-07-17360
K911248SYNERMED UREA NITROGEN REAGENT KITSynermed, Inc.1991-06-03740
K903543SYNERMED ALBUMIN REAGENT KITSynermed, Inc.1990-10-12660
K903773SYNERMED LDH REAGENT KITSynermed, Inc.1990-10-12530
K903233SYNERMED CALCIUM REAGENT KITSynermed, Inc.1990-10-04730
K903015SYNERMED CHOLESTEROL REAGENT KITSynermed, Inc.1990-10-01830
K903727SYNERMED URIC ACID REAGENT KITSynermed, Inc.1990-09-27420
K904030SYNERMED ALKALINE PHOSPHATASE REAGENT KITSynermed, Inc.1990-09-27270
K903728SYNERMED DIRECT BILIRUBIN REAGENT KITSynermed, Inc.1990-09-21360
K903063SYNERMED GLUCOSE REAGENT KITSynermed, Inc.1990-09-13660
K903511SYNERMED TOTAL PROTEIN REAGENT KITSynermed, Inc.1990-09-07350
K903296SYNERMED CREATININE REAGENT KITSynermed, Inc.1990-08-17240
K903103SYNERMED CHLORIDE REAGENT KITSynermed, Inc.1990-08-09270
K902919SYNERMED MAGNESIUM REAGENT KITSynermed, Inc.1990-07-31280
K902918SYNERMED SERUM IRON REAGENT KITSynermed, Inc.1990-07-31280
K903016SYNERMED TRIGLYCERIDES REAGENT KITSynermed, Inc.1990-07-27170
K902328SYNERMED TOTAL BILIRUBIN REAGENT KITSynermed, Inc.1990-06-28350

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