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

Ortho Diagnostics, Inc. — Predicate Candidate Screening

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

38 daysmedian FDA review time

95 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K802404	ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE	Ortho Diagnostics, Inc.	1980-10-23	17
K801507	ANTIGEN CONTROL CELLS	Ortho Diagnostics, Inc.	1980-08-20	51
K800357	BI-LEVEL ASSAYED CARD. DRUG CONT., I,II	Ortho Diagnostics, Inc.	1980-04-16	56
K800310	ORTHO ANTISERA CONTROL	Ortho Diagnostics, Inc.	1980-03-05	22
K791791	ORTHO ANTIBODY ENHANCEMENT SOLUTION	Ortho Diagnostics, Inc.	1979-10-11	30
K791301	ORTHO TSH RIA KIT	Ortho Diagnostics, Inc.	1979-09-24	70
K790813	MULTECON BLOOD GAS CONTROL	Ortho Diagnostics, Inc.	1979-06-28	62
K782166	SLIDE TEST FOR PREGNANCY, GRAVINDEX 90	Ortho Diagnostics, Inc.	1979-04-04	96
K782063	PREGNANCY, SENSIDEX TUBE TEST	Ortho Diagnostics, Inc.	1979-04-04	114
K781638	RUBINDEX*DIRECT SYSTEM	Ortho Diagnostics, Inc.	1978-12-20	90
K781860	ASSAY, CHROMOGENIC ANTITHROMBIN III	Ortho Diagnostics, Inc.	1978-12-04	28
K781572	NORMAL HEMATOLOGY CONTROL UNASSAYED	Ortho Diagnostics, Inc.	1978-10-17	33
K781573	ABNORMAL HEMATOLOGY CONTROL UNASSAYED	Ortho Diagnostics, Inc.	1978-10-17	33
K781482	ORTHO*T-3 UPTAKE KIT	Ortho Diagnostics, Inc.	1978-09-27	30
K781481	ORTHO*T-3 RIA (PEG) KIT	Ortho Diagnostics, Inc.	1978-09-27	30
K781483	ORTHO*T-4 RIA (PEG) KIT	Ortho Diagnostics, Inc.	1978-09-27	30
K781435	ORTHO LOW IONIC SOLUTION	Ortho Diagnostics, Inc.	1978-09-14	29
K781335	DIGOXIN RIA (PEG) KIT	Ortho Diagnostics, Inc.	1978-08-31	29
K781104	PLASMA COAGULATION CONT., ABNORMAL	Ortho Diagnostics, Inc.	1978-08-10	38
K780002	ANTITHROMBIN III ASSAY	Ortho Diagnostics, Inc.	1978-01-31	32
K771487	LEWIS BLOOD GROUP SUBSTANCE	Ortho Diagnostics, Inc.	1977-11-08	95
K771488	P1 BLOOD GROUP SUBSTANCE	Ortho Diagnostics, Inc.	1977-11-08	95
K771814	REAGENT CONFIDENCE SERA	Ortho Diagnostics, Inc.	1977-11-07	41
K761137	MICROSAMPLE BLOOD COLLECTION DEVICE	Ortho Diagnostics, Inc.	1977-02-07	75

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