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

Hillcrest Biologicals — Predicate Candidate Screening

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

94 daysmedian FDA review time

418 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K913617	ARBOVIRUS IGG IFA TEST	Hillcrest Biologicals	1992-12-03	478
K913618	ARBOVIRUS IGM IFA TEST	Hillcrest Biologicals	1992-12-03	478
K922374	Q FEVER IGM IFA TEST	Hillcrest Biologicals	1992-10-21	154
K913906	Q FEVER IGG IFA TEST	Hillcrest Biologicals	1992-10-21	418
K900206	LYME DISEASE IGM ELISA	Hillcrest Biologicals	1991-06-28	528
K896594	EBV VCA ANTIBODY (IGM)	Hillcrest Biologicals	1990-01-16	56
K884829	EBV EARLY ANTIGEN (R+D)	Hillcrest Biologicals	1989-04-12	145
K883767	LYME DISEASE IFA (IGM)	Hillcrest Biologicals	1989-03-15	190
K884591	EBV-VCA ANTIBODY (IGG)	Hillcrest Biologicals	1989-01-24	82
K883487	LYME DISEASE IFA (IGG)	Hillcrest Biologicals	1988-12-13	119
K875170	EBNA ANTIBODY	Hillcrest Biologicals	1988-05-23	158
K880476	LYME DISEASE ELISA	Hillcrest Biologicals	1988-04-26	82
K880417	LEPTOSPIROSIS IHA	Hillcrest Biologicals	1988-04-12	71
K864110	RICKETTSIAL IGG AND IGM IFA KIT	Hillcrest Biologicals	1987-03-12	142
K854715	TRANSPORT CULTURE MEDIA	Hillcrest Biologicals	1985-12-23	31
K853156	ECHO TYPE 16 CF ANTIGEN	Hillcrest Biologicals	1985-11-07	100
K853165	ECHO TYPE 30 CF ANTIGEN	Hillcrest Biologicals	1985-11-07	100
K853279	COXSACKIE A2 CF ANTIGEN, A4, A10 & A16	Hillcrest Biologicals	1985-11-07	94
K853278	POLIO TYPE I CF ANTIGEN, & TYPE II, III	Hillcrest Biologicals	1985-11-07	94
K853277	CMV CF ANTIGEN	Hillcrest Biologicals	1985-11-07	94
K853157	ECHO TYPE 11 CF ANTIGEN	Hillcrest Biologicals	1985-11-07	100
K852494	CMV-IHA	Hillcrest Biologicals	1985-09-16	96
K853448	HILLCREST AMEBIASIS IHA TEST	Hillcrest Biologicals	1985-08-28	12
K850609	HERPES SIMPLEX GROUP CF ANTIGEN	Hillcrest Biologicals	1985-05-09	83
K850537	CELL CULTURE REFEED MEDIUM	Hillcrest Biologicals	1985-03-20	37
K844967	ECHO TYPE 9 CF ANTIGEN	Hillcrest Biologicals	1985-03-05	71
K844695	ECHO TYPE 4 CF ANTIGEN	Hillcrest Biologicals	1985-03-05	92
K850003	COXSACKIE B SERIES CF ANTIGENS	Hillcrest Biologicals	1985-03-05	62
K844868	CHLAMYDIA GROUP CF ANTIGEN	Hillcrest Biologicals	1985-03-05	81
K850124	CHLAMYDIAL TRANSPORT MEDIA	Hillcrest Biologicals	1985-03-04	49
K844747	VIRAL TRANSPORT MEDIA	Hillcrest Biologicals	1985-01-04	29
K834338	MYCOPLASMA PNEUMONIAE CF ANTIGEN	Hillcrest Biologicals	1984-02-27	77
K822095	HERPES-IHA KIT	Hillcrest Biologicals	1983-04-05	263

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