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

Bhp Diagnostix, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time

82 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K904503	SERACON CR REFERENCE	Bhp Diagnostix, Inc.	1990-11-02	31
K863648	SERACON CT REFERENCE	Bhp Diagnostix, Inc.	1986-10-29	41
K862594	SERACON(TM) CAL (PRODUCT NO. DO35)	Bhp Diagnostix, Inc.	1986-08-19	42
K844927	QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS	Bhp Diagnostix, Inc.	1985-03-22	93
K844928	QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE	Bhp Diagnostix, Inc.	1985-03-22	93
K844027	SERACON TM SR III	Bhp Diagnostix, Inc.	1984-11-27	43
K844026	SERACON TM SR IV	Bhp Diagnostix, Inc.	1984-11-27	43
K792486	SERACON-SRI (PROD. # D029	Bhp Diagnostix, Inc.	1979-12-31	28
K792485	SERACON-SRI	Bhp Diagnostix, Inc.	1979-12-31	28
K792487	SERACON-SRII	Bhp Diagnostix, Inc.	1979-12-31	28
K791958	SERACON - EL DO27	Bhp Diagnostix, Inc.	1979-10-17	16
K791957	SERACON -LO DO26	Bhp Diagnostix, Inc.	1979-10-11	10
K791956	SERACON CAL D025	Bhp Diagnostix, Inc.	1979-10-11	10
K782039	SERACON-N	Bhp Diagnostix, Inc.	1979-02-26	82
K782170	SERACON-LP	Bhp Diagnostix, Inc.	1979-02-15	48
K782171	SERACON-HDL	Bhp Diagnostix, Inc.	1979-02-08	41
K782037	SERACON-A	Bhp Diagnostix, Inc.	1979-02-08	64
K782038	SERACON-C	Bhp Diagnostix, Inc.	1979-02-08	64
K781758	SERACON-SRII	Bhp Diagnostix, Inc.	1978-12-04	49
K781757	SERACON-SRI	Bhp Diagnostix, Inc.	1978-12-04	49
K781786	QUANTICEL HHR # L500 AND L501	Bhp Diagnostix, Inc.	1978-11-15	27
K781745	QUANTICEL HHR, L531 AND L532	Bhp Diagnostix, Inc.	1978-11-15	26
K781247	QUANTICEL-HRP	Bhp Diagnostix, Inc.	1978-09-14	55
K780980	PLATELET CONTROL	Bhp Diagnostix, Inc.	1978-07-27	45
K780714	PLATELET CONTROL	Bhp Diagnostix, Inc.	1978-06-06	39

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