Company ยท US
Diagnostic Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1991. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 5 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 |
| JPK | Mixture, Hematology Quality Control | 3 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 |
| HIS | Condom | 1 |
| JCM | Control, Hemoglobin, Abnormal | 1 |
| KRX | Calibrator For Cell Indices | 1 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
| LSE | Epstein-Barr Virus, Other | 1 |
| LSR | Reagent, Borrelia Serological Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 5, 1991 | K896378 | LYME-CHECK(TM) TEST KIT Diagnostic Technology, Inc. | LSR |
| Oct 16, 1990 | K903612 | EBV/EA-CHECK TM TEST KIT Diagnostic Technology, Inc. | LSE |
| Jun 20, 1989 | K891542 | EBNA-CHECK(TM) TEST KIT Diagnostic Technology, Inc. | LLM |
| Jun 20, 1989 | K890819 | HSV-CHECK(TM) TEST KIT Diagnostic Technology, Inc. | HIS |
| Jun 20, 1989 | K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT Diagnostic Technology, Inc. | LJN |
| Jun 25, 1987 | K871373 | EBV-CHECK(TM) TEST KIT (IGG) Diagnostic Technology, Inc. | GNP |
| Apr 29, 1987 | K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT Diagnostic Technology, Inc. | LJP |
| Nov 28, 1986 | K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES Diagnostic Technology, Inc. | GNP |
| May 7, 1986 | K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS Diagnostic Technology, Inc. | GKL |
| Apr 4, 1986 | K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 Diagnostic Technology, Inc. | GKL |
| Nov 5, 1985 | K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 Diagnostic Technology, Inc. | GKL |
| Nov 30, 1984 | K841809 | COUNT-A-PART PLUS Diagnostic Technology, Inc. | JPK |
| Aug 16, 1984 | K842140 | PICOSCAL BLOOD CELL COUNTER PS-4 Diagnostic Technology, Inc. | GKL |
| Feb 10, 1984 | K834372 | PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ Diagnostic Technology, Inc. | GKL |
| Feb 10, 1984 | K834345 | IM-CHECK Diagnostic Technology, Inc. | KTN |
| Feb 4, 1984 | K834346 | BHCG-CHECK Diagnostic Technology, Inc. | JHJ |
| Jun 22, 1983 | K831468 | B HCG-CHECK Diagnostic Technology, Inc. | JHJ |
| Jun 22, 1983 | K831466 | HCG-CHECK Diagnostic Technology, Inc. | JHJ |
| Jun 16, 1983 | K831464 | ASO-CHECK Diagnostic Technology, Inc. | GTQ |
| Jun 8, 1983 | K831467 | RA-CHECK Diagnostic Technology, Inc. | DHR |
| Jun 8, 1983 | K831465 | CRP-CHECK Diagnostic Technology, Inc. | DCN |
| Jun 8, 1983 | K831463 | ANA-CHECK Diagnostic Technology, Inc. | LKJ |
| Apr 21, 1982 | K827289 | DIGITAL RADIOGRAPHY SYSTEM Diagnostic Technology, Inc. | |
| Feb 4, 1982 | K820037 | SICKLE-CHECK Diagnostic Technology, Inc. | JCM |
| Jul 1, 1981 | K811063 | LASER-CAL Diagnostic Technology, Inc. | KRX |
| Oct 11, 1979 | K791772 | COUNTER-CHECK PLUS NORMAL, HIGH ABN. Diagnostic Technology, Inc. | JPK |
| Oct 11, 1979 | K791750 | COUNTER-CHECK PLUS Diagnostic Technology, Inc. | JPK |
| Jan 17, 1979 | K790025 | COUNTER CHECK, H001, H002, H003 Diagnostic Technology, Inc. | KSF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||