Atlas FDA

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

Ampcor, Inc. — Predicate Candidate Screening

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

60 daysmedian FDA review time
154 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TESTAmpcor, Inc.1992-07-14600
K922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TESTAmpcor, Inc.1992-07-14600
K910438DIPSTICK SALMONELLAAmpcor, Inc.1991-09-132250
K893873SINGLE AND DUAL BAND DIPSTICK HCG TESTAmpcor, Inc.1989-08-21870
K890048QUIK-DOT TOXOPLASMOSISAmpcor, Inc.1989-06-091540
K892146C REACTIVE PROTEIN LIQUIDAmpcor, Inc.1989-04-14140
K892119QUIK-DOT C REACTIVE PROTEINAmpcor, Inc.1989-04-14140
K890025QUIK-DOT ANTISTREPTOLYSIN-OAmpcor, Inc.1989-01-31270
K884750GROUP A STREP, BETA-STREPAmpcor, Inc.1988-12-22380
K880163PREGNANCY (HCG) CARD & LIQUID TESTAmpcor, Inc.1988-05-171250
K880478PREGNANCY BETA-HCG CARD & LIQUID TESTAmpcor, Inc.1988-04-28840
K880165TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMAAmpcor, Inc.1988-03-30770
K880477RPR TEST FOR SYPHILIS IN SERUM OR PLASMAAmpcor, Inc.1988-03-30550
K880148INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TESTAmpcor, Inc.1988-02-10280
K880164RF CARD TEST & RF LIQUID TESTAmpcor, Inc.1988-02-10280

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