Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Dynatech Corp. — Predicate Candidate Screening

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

23 daysmedian FDA review time

77 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K904567	DYNATECH MR4000 MICROPLATE READER	Dynatech Corp.	1991-01-28	111
K854604	AUTO MASH	Dynatech Corp.	1985-12-06	18
K854603	MULTI MASH 2000	Dynatech Corp.	1985-12-06	18
K854602	MINI MASH 2000	Dynatech Corp.	1985-12-06	18
K832117	IMMULON SUBSTRATE REMOVAWELL STRIPS	Dynatech Corp.	1983-08-08	39
K823787	HANDI-WASH	Dynatech Corp.	1983-03-09	83
K823833	MICRO STIX #011-010-5000 & HOLDER#5100	Dynatech Corp.	1983-03-08	77
K830200	MICROELISA MINIREADER II	Dynatech Corp.	1983-02-16	27
K823773	PROVIAL II #006-010-0201	Dynatech Corp.	1983-01-21	38
K823557	REMOVAWELL PLATE LID	Dynatech Corp.	1982-12-28	26
K822960	MICROFLUOR B PLATE & MICRO FLUOR W PLATE	Dynatech Corp.	1982-11-16	42
K822962	MICROFLUOR B REMOVAWELL STRIPS	Dynatech Corp.	1982-11-16	42
K822772	MICROFLUOR READER	Dynatech Corp.	1982-10-27	43
K821687	REMOVAWELL TISSUE CULTURE PLATE W/LID	Dynatech Corp.	1982-06-24	16
K821439	MR 600 MICROPLATE READER	Dynatech Corp.	1982-06-01	19
K820821	MIC-2000 PLUS, 96 CHANNEL DISPENSER	Dynatech Corp.	1982-04-14	21
K813640	MINIWASH II	Dynatech Corp.	1982-01-28	28
K813318	MINI-SHAKER	Dynatech Corp.	1981-12-17	23
K811001	MICROERMA SYSTEM	Dynatech Corp.	1981-05-01	18
K810968	BCD-HPP41C INTERFACE	Dynatech Corp.	1981-04-23	14
K810719	REPLICA PLATER	Dynatech Corp.	1981-04-01	15
K810659	AUTODILUTER III	Dynatech Corp.	1981-03-31	20
K810509	DIGITAL DISPENSING PUMP	Dynatech Corp.	1981-03-06	10
K810039	MIC-2000 INOCULUM TRAY LID	Dynatech Corp.	1981-01-28	19
K810022	SRD III	Dynatech Corp.	1981-01-26	21
K802857	IMMULON REMOVAWELL STRIPS #011-010-6301	Dynatech Corp.	1980-12-11	29
K790103	NEPHELOMETER, MIC-2000 LASER	Dynatech Corp.	1979-03-12	55

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