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

Monoclonal Antibodies, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time
113 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)Monoclonal Antibodies, Inc.1988-02-16830
K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)Monoclonal Antibodies, Inc.1987-07-27830
K863744HCG CONTROL KITMonoclonal Antibodies, Inc.1986-11-05420
K860924RAMP PROGESTURINE PDG ASSAY--48 TEST KITMonoclonal Antibodies, Inc.1986-07-021130
K854611RAMP URINE HCG ASSAYMonoclonal Antibodies, Inc.1985-12-30420
K850730MODEL SERUM HCG ASSAYMonoclonal Antibodies, Inc.1985-04-02390
K850480OVU STICK SELF-TEST -MODIFICATIONMonoclonal Antibodies, Inc.1985-03-05340
K843284OVUSTICK SELF-TESTMonoclonal Antibodies, Inc.1984-12-111130
K840738PLUS URINE HCG ASSAYMonoclonal Antibodies, Inc.1984-04-19580
K840412OVU STICK URINE HLH KITMonoclonal Antibodies, Inc.1984-04-13730
K833504PREGNASTICK URINE HCG KITMonoclonal Antibodies, Inc.1984-01-09960
K832562SERUM HCG ASSAYMonoclonal Antibodies, Inc.1983-09-12410
K831155B-CLONE HCG ASSAYMonoclonal Antibodies, Inc.1983-06-02550
K822520MODEL UCG ASSAYMonoclonal Antibodies, Inc.1982-09-28360

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