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

Derma Media Lab., Inc. — Predicate Candidate Screening

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

82 daysmedian FDA review time

115 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K971309	UREA	Derma Media Lab., Inc.	1997-08-01	115
K970664	GLUCOSE REAGENT	Derma Media Lab., Inc.	1997-08-01	161
K971072	CHOLESTEROL REAGENT	Derma Media Lab., Inc.	1997-06-20	88
K970867	URIC ACID REAGENT	Derma Media Lab., Inc.	1997-04-21	42
K971005	TRIGLYCERIDES	Derma Media Lab., Inc.	1997-04-21	33
K964915	MAGNESIUM	Derma Media Lab., Inc.	1997-03-26	107
K964913	IRON REAGENT	Derma Media Lab., Inc.	1997-02-20	73
K965134	ALT/SGPT	Derma Media Lab., Inc.	1997-02-18	57
K964914	ALKALINE PHOSPHATASE	Derma Media Lab., Inc.	1997-02-04	57
K965126	AST/SGOT	Derma Media Lab., Inc.	1997-01-17	25
K964916	GAMMA-GLUTAMYL TRANSPEPTIDASE	Derma Media Lab., Inc.	1997-01-10	32
K964912	LACTATE DEHYDROGENASE	Derma Media Lab., Inc.	1997-01-09	31
K955781	ALBUMIN	Derma Media Lab., Inc.	1996-03-13	83
K955939	CALCIUM REAGENT	Derma Media Lab., Inc.	1996-03-13	83
K955940	TOTAL BILIRUBIN REAGENT	Derma Media Lab., Inc.	1996-03-13	83
K955938	CREATININE REAGENT	Derma Media Lab., Inc.	1996-03-12	82
K955936	TOTAL PROTEIN REAGENT	Derma Media Lab., Inc.	1996-03-12	82
K955937	INORGANIC PHOSPHORUS REAGENT	Derma Media Lab., Inc.	1996-03-12	82

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