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

Antibodies, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time

48 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K890774	GIARDEIA(TM)	Antibodies, Inc.	1989-04-04	48
K843590	DETECT-A-STREP	Antibodies, Inc.	1984-10-30	48
K822892	CORTISOL RIA KIT	Antibodies, Inc.	1982-11-01	34
K812749	ULTRA-DIG	Antibodies, Inc.	1981-10-19	20
K812314	CRITHIDNA ANTI-DNA TEST KIT	Antibodies, Inc.	1981-09-01	15
K802877	AMIKACIN RIA KIT	Antibodies, Inc.	1980-12-19	32
K800743	TOBRAMYCIN RIA KIT	Antibodies, Inc.	1980-04-16	13
K791217	TSH RIA KIT	Antibodies, Inc.	1979-09-04	64
K781653	NEPHELRATE ANTISERUMS C3C	Antibodies, Inc.	1978-11-08	42
K781655	NEPHELRATE ANTISERUMS 1GA	Antibodies, Inc.	1978-11-08	42
K781654	NEPHELRATE ANTIPERUMS LGM	Antibodies, Inc.	1978-11-08	42
K781656	NEPHELRATE ANTISERUMS, IGG	Antibodies, Inc.	1978-11-08	42
K780516	GENTAMICIN RIA KIT	Antibodies, Inc.	1978-04-28	29
K772122	T3 RIA KIT	Antibodies, Inc.	1977-11-17	7
K771877	DIGOXIN RIA KIT	Antibodies, Inc.	1977-10-21	17
K771585	T3 UPTAKE DIAG. KIT	Antibodies, Inc.	1977-09-13	26

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