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

Whittaker Bioproducts, Inc. — Predicate Candidate Screening

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

89 daysmedian FDA review time

351 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K911356	LEGIONELLA STAT IGG/IGM TEST KIT	Whittaker Bioproducts, Inc.	1992-07-30	490
K913212	3M IGE SINGLE POINT FAST TEST	Whittaker Bioproducts, Inc.	1991-11-22	126
K904652	LYME STAT M TEST KIT	Whittaker Bioproducts, Inc.	1991-10-21	371
K904893	FIAX LYME M TEST KIT	Whittaker Bioproducts, Inc.	1991-10-16	351
K911473	EBNA STAT TEST KIT	Whittaker Bioproducts, Inc.	1991-09-25	174
K904738	PYLORI STAT TEST KIT	Whittaker Bioproducts, Inc.	1991-05-07	201
K905468	PYLORI-G FIAX TEST KIT	Whittaker Bioproducts, Inc.	1991-05-07	152
K901493	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B	Whittaker Bioproducts, Inc.	1990-06-27	90
K893579	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A	Whittaker Bioproducts, Inc.	1990-01-16	252
K894932	FIAX EB VCA-M TEST KIT	Whittaker Bioproducts, Inc.	1989-10-16	74
K894235	EB VCA STAT M TEST KIT	Whittaker Bioproducts, Inc.	1989-08-30	71
K891086	STAT TEST KIT FOR EB-VCA IGG ANTIBODY	Whittaker Bioproducts, Inc.	1989-05-10	70
K885310	MURINE MONOCLONAL ANTI-ADENOVIRUS IGG	Whittaker Bioproducts, Inc.	1989-02-16	49
K884516	FITC MURINE MONOCLONAL ANTI-RSV IGG	Whittaker Bioproducts, Inc.	1989-01-13	78
K883352	FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI	Whittaker Bioproducts, Inc.	1988-10-06	58
K882024	FITC MURINE MONOCLONAL ANTI-CMV IGG	Whittaker Bioproducts, Inc.	1988-08-03	78
K882023	FIAX TEST KIT FOR EB-VCA-G ANTIBODY	Whittaker Bioproducts, Inc.	1988-08-03	78
K881180	FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG	Whittaker Bioproducts, Inc.	1988-05-13	66
K880996	FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG	Whittaker Bioproducts, Inc.	1988-05-13	66
K875113	TOXOSTAT M TEST KIT	Whittaker Bioproducts, Inc.	1988-04-12	119
K875286	LYME STAT TEST KIT	Whittaker Bioproducts, Inc.	1988-03-30	92
K873708	FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES	Whittaker Bioproducts, Inc.	1987-11-25	71
K872247	FIAX TEST KIT FOR LYME DISEASE ANTIBODIES	Whittaker Bioproducts, Inc.	1987-10-15	126
K872733	FIAX TEST KIT FOR MUMPS-G ANTIBODIES	Whittaker Bioproducts, Inc.	1987-10-06	89
K863798	FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES	Whittaker Bioproducts, Inc.	1987-04-14	197
K863434	THE FIAX 5000 FLUOROMETER	Whittaker Bioproducts, Inc.	1986-10-29	55
K861716	FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY	Whittaker Bioproducts, Inc.	1986-08-08	94
K854839	CYTOMEGELISA M TEST KIT	Whittaker Bioproducts, Inc.	1986-02-04	62
K844552	BIO-STAT III PLATE WASHER	Whittaker Bioproducts, Inc.	1985-01-30	70
K843904	DNA STAT TEST KIT	Whittaker Bioproducts, Inc.	1984-11-01	29

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