Company ยท US
American Diagnostic Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2017. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQD | Stethoscope, Electronic | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 |
| DXQ | Blood Pressure Cuff | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| GIZ | Plasma, Control, Normal | 1 |
| HLJ | Ophthalmoscope, Battery-Powered | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 |
| KHE | Reagent, Occult Blood | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2017 | K162589 | Adscope 658 Electronic Stethoscope American Diagnostic Corp. | DQD |
| Nov 19, 2010 | K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS American Diagnostic Corp. | HLJ |
| May 15, 2006 | K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK American Diagnostic Corp. | DQD |
| Nov 1, 2001 | K012304 | ADC 656 ELECTRONIC STETHOSCOPE American Diagnostic Corp. | DQD |
| Jan 27, 1997 | K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS American Diagnostic Corp. | DXQ |
| Jul 8, 1994 | K940686 | ELECTRONIC THERMOMETERS American Diagnostic Corp. | FLL |
| Mar 3, 1994 | K935944 | PROSCOPES AND ADSCOPES American Diagnostic Corp. | LDE |
| Oct 18, 1993 | K932145 | COAGULATION REFERENCE PLASMA, NORMAL American Diagnostic Corp. | GIZ |
| Sep 18, 1989 | K894169 | BIOTEL MICROALBUMINURIA (TM) American Diagnostic Corp. | JIR |
| Jun 23, 1989 | K893608 | ACTICHROME ATIII KIT American Diagnostic Corp. | JBQ |
| Mar 13, 1989 | K884941 | ACTICLOT C KIT American Diagnostic Corp. | GGP |
| Mar 13, 1989 | K884940 | RELLPLATE C KIT, RELLPLATE C BULK PLATES American Diagnostic Corp. | GGP |
| Mar 6, 1987 | K870500 | MAJOR QUALITY GLUCOSE AND KETONES URINE TEST American Diagnostic Corp. | JIL |
| Jun 13, 1986 | K855239 | BIOTEL (TM)/ DIABETES American Diagnostic Corp. | JIL |
| May 9, 1986 | K855238 | BIOTEL (TM)/UTI American Diagnostic Corp. | JMT |
| May 6, 1986 | K855237 | BIOTEL (TM)/ KIDNEY American Diagnostic Corp. | KHE |
| Sep 12, 1983 | K832493 | QUINIDINE FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LBZ |
| Jun 2, 1983 | K831377 | IGE RADIOIMMUNOASSAY KIT American Diagnostic Corp. | DGC |
| Nov 10, 1982 | K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA American Diagnostic Corp. | KJI |
| Oct 26, 1982 | K822941 | NETILMICIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LCE |
| Aug 25, 1982 | K822347 | LIDOCAINE FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | KLR |
| Aug 16, 1982 | K822308 | VANCOMYCIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LEH |
| Aug 12, 1982 | K822229 | PRIMIDONE FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LFT |
| Jul 16, 1982 | K821945 | CARBAMAZEPINE FLOURESCENT IMMUNOASSAY American Diagnostic Corp. | KLT |
| Jul 2, 1982 | K821807 | AMERIFLOUR FLUOROMETER American Diagnostic Corp. | JQP |
| May 24, 1982 | K821408 | PHENOBARBITAL FLUORESCENT IMMUNO American Diagnostic Corp. | LET |
| Mar 2, 1982 | K820397 | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM American Diagnostic Corp. | LER |
| Feb 23, 1982 | K820274 | DIGOXIN RADIOIMMUNOASSAY American Diagnostic Corp. | DPB |
| Jan 12, 1982 | K813542 | TOBRAMYCIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LCR |
| Jan 12, 1982 | K813541 | AMIKACIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | KLQ |
| Dec 31, 1981 | K813540 | A FLUOROMETER American Diagnostic Corp. | KHO |
| Dec 31, 1981 | K813539 | GENTAMICIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LCQ |
| Dec 31, 1981 | K813538 | PHENYTOIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LES |
| Jan 9, 1981 | K803098 | TRI-LEVEL RADIOASSAY CONTROL SERA American Diagnostic Corp. | JJY |
| Dec 18, 1980 | K802841 | DIGOXIN RADIOIMMUNOASSAY KIT American Diagnostic Corp. | DNL |
| Nov 12, 1980 | K802470 | T3 RADIOIMMUNOASSAY KIT American Diagnostic Corp. | CDP |
| Nov 12, 1980 | K802469 | T4 RADIOIMMUNOASSAY KIT American Diagnostic Corp. | CDX |
| Oct 31, 1980 | K802468 | T3 UPTAKE TEST SYSTEM American Diagnostic Corp. | KHQ |
| Oct 31, 1980 | K802467 | TSH RADIOIMMUNOASSAY KIT American Diagnostic Corp. | JLW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||