Atlas FDA

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

Microscan Div. Baxter Healthcare Corp. — Predicate Candidate Screening

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

91 daysmedian FDA review time
93 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K871229ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELLMicroscan Div. Baxter Healthcare Corp.1987-06-26910
K871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1Microscan Div. Baxter Healthcare Corp.1987-06-26910
K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BMicroscan Div. Baxter Healthcare Corp.1987-06-26910
K871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2Microscan Div. Baxter Healthcare Corp.1987-06-26910
K871230ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUSMicroscan Div. Baxter Healthcare Corp.1987-06-26910
K871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AMicroscan Div. Baxter Healthcare Corp.1987-06-26910
K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3Microscan Div. Baxter Healthcare Corp.1987-06-26910
K870814HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2Microscan Div. Baxter Healthcare Corp.1987-06-04930
K870074GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELSMicroscan Div. Baxter Healthcare Corp.1987-04-14969
K871033RABBIT KIDNEY CULTURE CELLS (FIRST PASS)Microscan Div. Baxter Healthcare Corp.1987-03-31150
K870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.1987-03-17670

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