Atlas FDA

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

Biocheck, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
185 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041619BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116Biocheck, Inc.2004-12-171850
K040030BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114Biocheck, Inc.2004-06-161610
K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.2002-12-191320
K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITBiocheck, Inc.2002-01-081180
K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASBiocheck, Inc.2001-07-202200
K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115Biocheck, Inc.2000-10-02670
K001022BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MBiocheck, Inc.2000-09-261800
K992517BIOCHECK FERRITIN ELISA MODEL BC-1025Biocheck, Inc.1999-09-24580
K992528BIOCHECK IGE ELISA, MODEL BC-1035Biocheck, Inc.1999-09-21550
K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027Biocheck, Inc.1999-07-22620
K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001Biocheck, Inc.1999-06-22780
K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; Biocheck, Inc.1999-06-22900
K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007Biocheck, Inc.1999-06-02371
K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.1999-06-02470

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