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

Precision Biologic — Predicate Candidate Screening

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

146 daysmedian FDA review time

305 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K193556	Cryocheck Hex LA	Precision Biologic	2020-10-23	305
K193204	Cryocheck Chromogenic Factor VIII	Precision Biologic	2020-07-17	240
K032804	CRYOCHECK WEAK LUPUS POSITIVE CONTROL	Precision Biologic	2003-11-03	55
K023991	CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50	Precision Biologic	2003-04-28	146
K023990	CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50	Precision Biologic	2003-03-19	106
K013708	REFERENCE CHECK, CATALOG NUMBER-RCN-10	Precision Biologic	2001-12-10	32
K990580	CRYOCHECK LA SURE, MODEL SUR25-10	Precision Biologic	1999-07-28	155
K990579	CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (	Precision Biologic	1999-07-23	150
K990814	CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02	Precision Biologic	1999-06-07	88
K990296	CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (	Precision Biologic	1999-03-18	49

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