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

Technostics Intl. — Predicate Candidate Screening

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

19 daysmedian FDA review time

37 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K855188	CPK (UV) REAGENT KIT	Technostics Intl.	1986-03-05	69
K860111	URIC ACID REAGENT SET	Technostics Intl.	1986-02-19	37
K855190	MAGNESIUM REAGENT SET	Technostics Intl.	1986-02-18	54
K860110	GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET	Technostics Intl.	1986-02-11	29
K860109	ENZYMATIC UREA NITROGEN REAGENT SET	Technostics Intl.	1986-02-06	24
K860112	TOTAL LIPIDS REAGENT SET	Technostics Intl.	1986-01-24	11
K855185	GLUCOSE REAGENT SET	Technostics Intl.	1986-01-22	27
K855157	LACTIC DEHYDROGENASE (VV) REAGENT SET	Technostics Intl.	1986-01-21	26
K855159	LACTIC DEHYDROGENASE REAGENT SET	Technostics Intl.	1986-01-14	19
K855158	ALBUMIN REAGENT SET	Technostics Intl.	1986-01-14	19
K855195	DIRECT & TOTAL BILIRUBIN SET	Technostics Intl.	1986-01-14	19
K855193	CREATININE REAGENT SET	Technostics Intl.	1986-01-14	19
K855194	GLUCOSE OXIDASE REAGENT SET	Technostics Intl.	1986-01-14	19
K855187	ENZYMATIC CHOLESTROL REAGENT SET	Technostics Intl.	1986-01-14	19
K855186	GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET	Technostics Intl.	1986-01-14	19
K855154	INORGANIC PHOSPHORUS REAGENT SET	Technostics Intl.	1986-01-14	19
K855153	GLUCOSE (UV HEXOKIASE) REAGENT SET	Technostics Intl.	1986-01-14	19
K855192	ALKALINE PHOSPHATASE REAGENT SET	Technostics Intl.	1986-01-14	19
K855189	GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET	Technostics Intl.	1986-01-14	19
K855156	GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET	Technostics Intl.	1986-01-14	19
K855191	TOTAL PROTEIN REAGENT SET	Technostics Intl.	1986-01-14	19

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