Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LAN — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
89 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060738 | TDM N-ACETYLPROCAINAMIDE | Roche Diagnostics Corp. | 2006-08-16 | 149 | 1 |
| K032564 | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2003-10-31 | 72 | 0 |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | Syva Co., Dade Behring, Inc. | 2001-06-18 | 24 | 0 |
| K983812 | NAPA EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-16 | 19 | 0 |
| K971713 | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-06-11 | 33 | 0 |
| K955422 | AXSYM N-ACETYLPROCAINAMIDE | Abbott Laboratories | 1996-04-24 | 148 | 0 |
| K934705 | OPUS NAPA | Pb Diagnostic Systems, Inc. | 1993-11-22 | 53 | 0 |
| K922915 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT | Syva Co. | 1992-08-24 | 68 | 0 |
| K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-25 | 49 | 0 |
| K873349 | EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 | Em Diagnostic Systems, Inc. | 1987-09-22 | 33 | 0 |
| K871680 | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR | Roche Diagnostic Systems, Inc. | 1987-06-08 | 40 | 0 |
| K860140 | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. | American Dade | 1986-02-06 | 23 | 0 |
| K853547 | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I | American Dade | 1985-09-16 | 21 | 0 |
| K852319 | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-06-25 | 25 | 0 |
| K851060 | EMIT QST N-ACETYLPROCAINAMIDE ASSAY | Syva Co. | 1985-04-05 | 21 | 0 |
| K833378 | N-ACETYLPROCAINAMIDE ACA-ANALYTICAL | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 | 89 | 0 |
| K832098 | N-ACETYLPROCAINAMIDE ASSAY FOR COBAS | Syva Co. | 1983-08-12 | 44 | 0 |
| K831399 | AMES TDA N-ACETYL-PROCAINAMIDE TEST | Miles Laboratories, Inc. | 1983-06-02 | 34 | 0 |
| K830206 | TDX N-ACETYLPROCAINAMIDE | Abbott Laboratories | 1983-02-18 | 28 | 0 |
| K823129 | ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE | Syva Co. | 1982-11-29 | 35 | 0 |
| K781378 | EMIT N-ACETYLPROCAINAMIDE ASSAY | Syva Co. | 1978-10-10 | 61 | 0 |
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