Company ยท US
Kallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1991. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | 4 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 |
| DHR | System, Test, Rheumatoid Factor | 3 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| DCN | System, Test, C-Reactive Protein | 2 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 2 |
| DEW | Igg, Antigen, Antiserum, Control | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| LIO | Device, Specimen Collection | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 |
| MSJ | Apolipoproteins | 2 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 1 |
| CZJ | Igd, Antigen, Antiserum, Control | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 1991 | K910887 | QM300 CONTROL G PACK Kallestad Diag, A Div. of Erbamont, Inc. | GTQ |
| Jun 17, 1991 | K910886 | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK Kallestad Diag, A Div. of Erbamont, Inc. | GTQ |
| Jun 17, 1991 | K910885 | QM300 CALIBRATOR G PACK Kallestad Diag, A Div. of Erbamont, Inc. | GTQ |
| Jan 14, 1991 | K904725 | CHLAMYDIA SYSTEM SOFTWARE (CSS) Kallestad Diag, A Div. of Erbamont, Inc. | LJC |
| Jul 26, 1990 | K902253 | PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT Kallestad Diag, A Div. of Erbamont, Inc. | LJC |
| Jun 21, 1990 | K902462 | MODIFIED QM300 RHEUMATOID FACTOR TEST Kallestad Diag, A Div. of Erbamont, Inc. | DHR |
| Apr 3, 1990 | K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR Kallestad Diag, A Div. of Erbamont, Inc. | JFT |
| Mar 29, 1990 | K900009 | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET Kallestad Diag, A Div. of Erbamont, Inc. | KLS |
| Mar 29, 1990 | K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR Kallestad Diag, A Div. of Erbamont, Inc. | KLI |
| Mar 23, 1990 | K894947 | PLATELIA TOXO IGG KIT Kallestad Diag, A Div. of Erbamont, Inc. | LGO |
| Mar 15, 1990 | K894948 | PLATELIA TOXO IGM KIT Kallestad Diag, A Div. of Erbamont, Inc. | LGD |
| Jan 22, 1990 | K900028 | ALLERCOAT MICROPLATE SYSTEM Kallestad Diag, A Div. of Erbamont, Inc. | JJQ |
| Dec 21, 1989 | K894946 | PLATELIA RUBELLA IGG KIT Kallestad Diag, A Div. of Erbamont, Inc. | LFX |
| Dec 1, 1989 | K896483 | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEB |
| Nov 6, 1989 | K896059 | MODIFIED QM300 ALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCF |
| Oct 31, 1989 | K894859 | LP 400 MICROPLATE READER Kallestad Diag, A Div. of Erbamont, Inc. | JJQ |
| Sep 21, 1989 | K895377 | QM300 CERULOPLASMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DDB |
| Aug 4, 1989 | K894538 | QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DBN |
| Dec 20, 1988 | K885001 | QM300 PCR ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCN |
| Nov 30, 1988 | K884517 | PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED Kallestad Diag, A Div. of Erbamont, Inc. | LJC |
| Nov 4, 1988 | K883537 | QM300 CONTROL E Kallestad Diag, A Div. of Erbamont, Inc. | DHB |
| Oct 19, 1988 | K883714 | QM300 APOLIPOPROTEIN B ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | MSJ |
| Oct 19, 1988 | K883713 | QM300 APOLIPOPROTEIN A-I ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | MSJ |
| Sep 22, 1988 | K883712 | QM300 CONTROL F PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFC |
| Sep 22, 1988 | K883711 | QM300 CALIBRATOR F PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFC |
| Sep 22, 1988 | K883002 | QM300 PREALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | JZJ |
| Sep 22, 1988 | K883001 | QM300 CALIBRATOR D PACK Kallestad Diag, A Div. of Erbamont, Inc. | CZJ |
| Sep 7, 1988 | K883538 | QM300 CALIBRATOR E PACK Kallestad Diag, A Div. of Erbamont, Inc. | DHR |
| Sep 7, 1988 | K883536 | QM300 RHEUMATOID FACTOR ANTIGEN PACK Kallestad Diag, A Div. of Erbamont, Inc. | DHR |
| Jul 8, 1988 | K882083 | QM300 IGG ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEW |
| Jul 8, 1988 | K882082 | QM300 ALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCF |
| Jun 6, 1988 | K881933 | KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST Kallestad Diag, A Div. of Erbamont, Inc. | JZO |
| Apr 21, 1988 | K881127 | QM300 CALIBRATOR D PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCF |
| Apr 12, 1988 | K880824 | PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT Kallestad Diag, A Div. of Erbamont, Inc. | LJC |
| Apr 6, 1988 | K881126 | QM300 ALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCF |
| Mar 30, 1988 | K880729 | KALLESTAD QM300 CALIBRATOR C PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCK |
| Mar 25, 1988 | K880730 | KALLESTAD QM2/QM300 CONTROL C PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCK |
| Mar 25, 1988 | K880728 | KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCN |
| Mar 23, 1988 | K881125 | PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT Kallestad Diag, A Div. of Erbamont, Inc. | LIO |
| Mar 17, 1988 | K880031 | PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS Kallestad Diag, A Div. of Erbamont, Inc. | LJP |
| Feb 17, 1988 | K875282 | QM300 CALIBRATOR B PACK Kallestad Diag, A Div. of Erbamont, Inc. | JIX |
| Feb 10, 1988 | K875283 | QM2/QM300 CONTROL B PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEM |
| Feb 10, 1988 | K875281 | QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEM |
| Jan 22, 1988 | K875165 | QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEH |
| Jan 22, 1988 | K875164 | QM300 KAPPA LIGHT CHAINS ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFH |
| Oct 7, 1987 | K873789 | QM300 TRANSFERRIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DDG |
| Jul 23, 1987 | K872599 | QM300 C4 ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DBI |
| Jul 21, 1987 | K872717 | QM300 HAPTOGLOBIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DAD |
| Jul 9, 1987 | K872237 | KALLESTAD QM300 IGM ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DFT |
| Jun 12, 1987 | K871940 | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL Kallestad Diag, A Div. of Erbamont, Inc. | CZP |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||