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

Bioscientific — Predicate Candidate Screening

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

22 daysmedian FDA review time

57 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K812447	AMYLASE REAGENT KIT	Bioscientific	1981-09-09	12
K811251	CITRATE BUFFER	Bioscientific	1981-05-21	16
K801265	WHITE BLOOD CELL COUNT CONTROL LEVELS	Bioscientific	1980-07-14	47
K801268	HEMOGLOBIN CONTROL LEVELS	Bioscientific	1980-07-14	47
K801267	RED BLOOD CELL COUNT & HEMATOCRIT CNTL	Bioscientific	1980-07-14	47
K791658	WRIGHT STAIN PACK	Bioscientific	1979-10-17	57
K791007	STAT DIFF STAIN	Bioscientific	1979-08-03	64
K790415	HCP-7	Bioscientific	1979-04-04	37
K781734	SODIUM CHLORIDE, 0.85%	Bioscientific	1978-10-24	12
K781585	HEMATOXYLIN STAIN HARRIS	Bioscientific	1978-10-10	22
K781582	PAPANICOLAOU STAIN EA-36	Bioscientific	1978-10-10	22
K781584	GRAM STAIN KIT	Bioscientific	1978-10-10	22
K781588	PAPANICOLAOU STIAN OG-6	Bioscientific	1978-10-10	22
K781587	HEMATOLOGY STAIN PACK	Bioscientific	1978-10-10	22
K781583	PAPANICOLAOU STAIN :EA-50:	Bioscientific	1978-10-10	22
K781643	ACID FAST KIT	Bioscientific	1978-10-03	8

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