Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GIZ — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
403 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060968 | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CAL | Wortham Laboratories, Inc. | 2007-05-15 | 403 | 0 |
| K042941 | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | 2004-12-02 | 38 | 0 |
| K023309 | CONTROL PLASMA N | Dade Behring, Inc. | 2002-11-01 | 29 | 0 |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | 2001-12-10 | 32 | 0 |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | 2001-03-01 | 128 | 0 |
| K001256 | CONTROL PLASMA N | Dade Behring, Inc. | 2000-05-24 | 35 | 0 |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | 1998-12-01 | 13 | 0 |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | 1997-10-31 | 59 | 0 |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROL | Cardiovascular Diagnostics, Inc. | 1996-08-13 | 95 | 0 |
| K941737 | SPECIALTY ASSAYED CONTROL-1 | Helena Laboratories | 1994-10-07 | 183 | 0 |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORM | American Diagnostica, Inc. | 1994-09-19 | 322 | 0 |
| K924403 | CONTROL PLASMA N | Behring Diagnostics, Inc. | 1994-02-22 | 540 | 0 |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | 1993-10-18 | 167 | 0 |
| K922021 | UNICALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 | 40 | 1 |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | 1990-12-28 | 38 | 0 |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 45 | 0 |
| K893784 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | 1989-06-23 | 32 | 0 |
| K893783 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | 1989-06-23 | 32 | 0 |
| K891179 | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 | 35 | 0 |
| K880712 | CLP NORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | 1988-05-06 | 74 | 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