Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Behring Diagnostics, Inc. — Predicate Candidate Screening
145 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
263 days90th percentile
145clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | Behring Diagnostics, Inc. | 1997-10-27 | 20 | 0 |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Behring Diagnostics, Inc. | 1997-10-20 | 73 | 0 |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Behring Diagnostics, Inc. | 1997-10-17 | 77 | 0 |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Behring Diagnostics, Inc. | 1997-09-12 | 66 | 0 |
| K972316 | OPUS D-DIMER | Behring Diagnostics, Inc. | 1997-09-09 | 81 | 0 |
| K972116 | VON WILLEBRAND REAGENT | Behring Diagnostics, Inc. | 1997-07-25 | 50 | 0 |
| K972011 | OPUS ETHANOL | Behring Diagnostics, Inc. | 1997-07-22 | 53 | 0 |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 | Behring Diagnostics, Inc. | 1997-06-25 | 55 | 0 |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Behring Diagnostics, Inc. | 1997-06-25 | 55 | 0 |
| K964595 | OPUS PSA TEST SYSTEM | Behring Diagnostics, Inc. | 1997-06-24 | 218 | 0 |
| K971725 | OPUS PROGESTERONE | Behring Diagnostics, Inc. | 1997-06-18 | 40 | 0 |
| K970645 | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | 1997-05-19 | 88 | 1 |
| K970431 | BEHRING COAGULATION SYSTEM | Behring Diagnostics, Inc. | 1997-05-05 | 90 | 1 |
| K964764 | OPUS BONE ALP | Behring Diagnostics, Inc. | 1997-01-24 | 58 | 0 |
| K964527 | N RHEUMATOLOGY STANDARD SL | Behring Diagnostics, Inc. | 1997-01-15 | 64 | 0 |
| K964687 | N LATEX CRP MONO REAGENT | Behring Diagnostics, Inc. | 1996-12-16 | 90 | 0 |
| K962968 | PROC APC ASSAY, PROC CONTROL PLASMA | Behring Diagnostics, Inc. | 1996-12-13 | 136 | 0 |
| K964062 | N PROTEIN STRANDARD SL | Behring Diagnostics, Inc. | 1996-11-21 | 42 | 0 |
| K964065 | N/T PROTEIN CONTROL SL | Behring Diagnostics, Inc. | 1996-11-06 | 27 | 0 |
| K963084 | OPUS CMV TEST SYSTEM-MODIFICATION | Behring Diagnostics, Inc. | 1996-10-09 | 62 | 0 |
| K955596 | N LATEX B2-MICROGLOBULIN REAGENT | Behring Diagnostics, Inc. | 1996-10-03 | 300 | 0 |
| K962519 | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS | Behring Diagnostics, Inc. | 1996-09-04 | 69 | 0 |
| K962866 | OPUS HLH | Behring Diagnostics, Inc. | 1996-08-23 | 31 | 0 |
| K962841 | OPUS MYOGLOBIN CONTROLS | Behring Diagnostics, Inc. | 1996-08-15 | 24 | 0 |
| K960257 | N ANTISERUM TO C1 INHIBITOR | Behring Diagnostics, Inc. | 1996-08-01 | 196 | 0 |
| K962407 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | 1996-07-29 | 38 | 0 |
| K962694 | OPUS B12 CONTROLS | Behring Diagnostics, Inc. | 1996-07-22 | 11 | 0 |
| K962406 | N CRP STANDARD SY | Behring Diagnostics, Inc. | 1996-07-16 | 25 | 0 |
| K962410 | N PROTEIN STANDARD PY | Behring Diagnostics, Inc. | 1996-07-16 | 25 | 0 |
| K962373 | N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 | Behring Diagnostics, Inc. | 1996-07-11 | 21 | 0 |
| K962523 | N LATEX CRP MONO REAGENT | Behring Diagnostics, Inc. | 1996-07-10 | 41 | 0 |
| K955278 | BEHRING COAGULATION TIMER | Behring Diagnostics, Inc. | 1996-05-30 | 195 | 0 |
| K960275 | OPUS CK-MB & TOTAL CK CONTROLS | Behring Diagnostics, Inc. | 1996-04-25 | 97 | 0 |
| K961206 | OPUS T3 CONTROLS | Behring Diagnostics, Inc. | 1996-04-23 | 27 | 0 |
| K955450 | PATHROMTIN SL | Behring Diagnostics, Inc. | 1996-04-19 | 142 | 1 |
| K955448 | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS | Behring Diagnostics, Inc. | 1996-02-23 | 86 | 0 |
| K955468 | OPUS PROLACTIN CONTROLS | Behring Diagnostics, Inc. | 1996-02-23 | 85 | 0 |
| K955857 | N PROTEIN STANDARS SY | Behring Diagnostics, Inc. | 1996-02-21 | 56 | 0 |
| K955858 | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | 1996-02-21 | 56 | 0 |
| K955284 | OPUS TROPONIN I | Behring Diagnostics, Inc. | 1996-01-25 | 70 | 0 |
| K954291 | OPUS TDM CONTROLS | Behring Diagnostics, Inc. | 1995-11-20 | 67 | 0 |
| K954144 | OPUS HCG CONTROLS | Behring Diagnostics, Inc. | 1995-10-06 | 31 | 0 |
| K953160 | OPUS T3 | Behring Diagnostics, Inc. | 1995-08-24 | 48 | 0 |
| K953097 | OPUS T4 CONTROLS | Behring Diagnostics, Inc. | 1995-08-24 | 52 | 0 |
| K953455 | OPUS B12 | Behring Diagnostics, Inc. | 1995-08-23 | 35 | 0 |
| K952593 | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | 1995-07-17 | 41 | 0 |
| K952594 | N PROTEIN STANDARD SY | Behring Diagnostics, Inc. | 1995-07-17 | 41 | 0 |
| K951434 | OPUS PROCAINAMIDE | Behring Diagnostics, Inc. | 1995-07-03 | 97 | 0 |
| K952309 | N LATEX IGA | Behring Diagnostics, Inc. | 1995-06-20 | 34 | 0 |
| K926551 | BEHRING FIBRINTIMER A | Behring Diagnostics, Inc. | 1995-04-18 | 838 | 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