Company ยท US
Behring Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1997. Name variants (Inc, Corp, punctuation) are merged.
145510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 7 |
| DHR | System, Test, Rheumatoid Factor | 5 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 5 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 5 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| JZW | Nephelometer | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 3 |
| GGC | Control, Plasma, Abnormal | 3 |
| GJT | Plasma, Coagulation Factor Deficient | 3 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 3 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 |
| CIJ | Saccharogenic, Amylase | 2 |
| CZW | Complement C3, Antigen, Antiserum, Control | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 1997 | K973832 | OPUS HLH CONTROLS Behring Diagnostics, Inc. | JJX |
| Oct 20, 1997 | K972929 | N ANTISERUM TO HUMAN ALBUMIN Behring Diagnostics, Inc. | DCF |
| Oct 17, 1997 | K972840 | N ANTISERUM TO HUMAN TRANSFERRIN Behring Diagnostics, Inc. | DDG |
| Sep 12, 1997 | K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM Behring Diagnostics, Inc. | DBF |
| Sep 9, 1997 | K972316 | OPUS D-DIMER Behring Diagnostics, Inc. | GHH |
| Jul 25, 1997 | K972116 | VON WILLEBRAND REAGENT Behring Diagnostics, Inc. | GGP |
| Jul 22, 1997 | K972011 | OPUS ETHANOL Behring Diagnostics, Inc. | DIC |
| Jun 25, 1997 | K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) Behring Diagnostics, Inc. | DKB |
| Jun 25, 1997 | K971596 | EMIT II OPIATES 300/2000 ASSAY Behring Diagnostics, Inc. | DJG |
| Jun 24, 1997 | K964595 | OPUS PSA TEST SYSTEM Behring Diagnostics, Inc. | LTJ |
| Jun 18, 1997 | K971725 | OPUS PROGESTERONE Behring Diagnostics, Inc. | JLS |
| May 19, 1997 | K970645 | BC THROMBIN REAGENT Behring Diagnostics, Inc. | GJA |
| May 5, 1997 | K970431 | BEHRING COAGULATION SYSTEM Behring Diagnostics, Inc. | JPA |
| Jan 24, 1997 | K964764 | OPUS BONE ALP Behring Diagnostics, Inc. | CIN |
| Jan 15, 1997 | K964527 | N RHEUMATOLOGY STANDARD SL Behring Diagnostics, Inc. | JIX |
| Dec 16, 1996 | K964687 | N LATEX CRP MONO REAGENT Behring Diagnostics, Inc. | DCH |
| Dec 13, 1996 | K962968 | PROC APC ASSAY, PROC CONTROL PLASMA Behring Diagnostics, Inc. | GGP |
| Nov 21, 1996 | K964062 | N PROTEIN STRANDARD SL Behring Diagnostics, Inc. | JIX |
| Nov 6, 1996 | K964065 | N/T PROTEIN CONTROL SL Behring Diagnostics, Inc. | JJY |
| Oct 9, 1996 | K963084 | OPUS CMV TEST SYSTEM-MODIFICATION Behring Diagnostics, Inc. | LFZ |
| Oct 3, 1996 | K955596 | N LATEX B2-MICROGLOBULIN REAGENT Behring Diagnostics, Inc. | JZG |
| Sep 4, 1996 | K962519 | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS Behring Diagnostics, Inc. | LCD |
| Aug 23, 1996 | K962866 | OPUS HLH Behring Diagnostics, Inc. | CEP |
| Aug 15, 1996 | K962841 | OPUS MYOGLOBIN CONTROLS Behring Diagnostics, Inc. | JJX |
| Aug 1, 1996 | K960257 | N ANTISERUM TO C1 INHIBITOR Behring Diagnostics, Inc. | DBA |
| Jul 29, 1996 | K962407 | N/T PROTEIN CONTROL PY Behring Diagnostics, Inc. | GIL |
| Jul 22, 1996 | K962694 | OPUS B12 CONTROLS Behring Diagnostics, Inc. | JJX |
| Jul 16, 1996 | K962410 | N PROTEIN STANDARD PY Behring Diagnostics, Inc. | JIX |
| Jul 16, 1996 | K962406 | N CRP STANDARD SY Behring Diagnostics, Inc. | JIX |
| Jul 11, 1996 | K962373 | N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 Behring Diagnostics, Inc. | DCK |
| Jul 10, 1996 | K962523 | N LATEX CRP MONO REAGENT Behring Diagnostics, Inc. | DCK |
| May 30, 1996 | K955278 | BEHRING COAGULATION TIMER Behring Diagnostics, Inc. | GGN |
| Apr 25, 1996 | K960275 | OPUS CK-MB & TOTAL CK CONTROLS Behring Diagnostics, Inc. | JJT |
| Apr 23, 1996 | K961206 | OPUS T3 CONTROLS Behring Diagnostics, Inc. | JJX |
| Apr 19, 1996 | K955450 | PATHROMTIN SL Behring Diagnostics, Inc. | GFO |
| Feb 23, 1996 | K955468 | OPUS PROLACTIN CONTROLS Behring Diagnostics, Inc. | JJX |
| Feb 23, 1996 | K955448 | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS Behring Diagnostics, Inc. | DLB |
| Feb 21, 1996 | K955858 | N/T PROTEIN CONTROL SY/L, M AND H Behring Diagnostics, Inc. | JJY |
| Feb 21, 1996 | K955857 | N PROTEIN STANDARS SY Behring Diagnostics, Inc. | CZW |
| Jan 25, 1996 | K955284 | OPUS TROPONIN I Behring Diagnostics, Inc. | MMI |
| Nov 20, 1995 | K954291 | OPUS TDM CONTROLS Behring Diagnostics, Inc. | DIF |
| Oct 6, 1995 | K954144 | OPUS HCG CONTROLS Behring Diagnostics, Inc. | JJX |
| Aug 24, 1995 | K953160 | OPUS T3 Behring Diagnostics, Inc. | CDP |
| Aug 24, 1995 | K953097 | OPUS T4 CONTROLS Behring Diagnostics, Inc. | JJX |
| Aug 23, 1995 | K953455 | OPUS B12 Behring Diagnostics, Inc. | CDD |
| Jul 17, 1995 | K952594 | N PROTEIN STANDARD SY Behring Diagnostics, Inc. | CZW |
| Jul 17, 1995 | K952593 | N/T PROTEIN CONTROL SY/L, M AND H Behring Diagnostics, Inc. | DAD |
| Jul 3, 1995 | K951434 | OPUS PROCAINAMIDE Behring Diagnostics, Inc. | LAR |
| Jun 20, 1995 | K952309 | N LATEX IGA Behring Diagnostics, Inc. | CZP |
| Apr 18, 1995 | K926551 | BEHRING FIBRINTIMER A Behring Diagnostics, Inc. | JPA |
Newest 50 of 145.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||