Atlas FDA

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

A-Kem, Inc. — Predicate Candidate Screening

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

74 daysmedian FDA review time
74 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.1988-12-15700
K884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.1988-12-09640
K884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.1988-12-09640
K884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMA-Kem, Inc.1988-12-09640
K882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEMA-Kem, Inc.1988-08-08460
K882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMA-Kem, Inc.1988-08-08460
K873128GLUCOSE REAGENT KITA-Kem, Inc.1987-10-23740
K873131CREATININE REAGENT KITA-Kem, Inc.1987-10-23740
K873129CARBON DIOXIDE REAGENT KITA-Kem, Inc.1987-10-23740
K873127CHLORIDE REAGENT KITA-Kem, Inc.1987-10-23740
K873132BUN REAGENT KITA-Kem, Inc.1987-10-23740
K873130WASH SOLUTION KITA-Kem, Inc.1987-10-23740
K873126SODIUM/POTASSIUM REAGENT KITA-Kem, Inc.1987-10-23740

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