Diagnostic Technology, Inc.
Mchenry, IL, US
Diagnostic Technology, Inc. appears in FDA device records in Mchenry, IL. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Diagnostic Technology, Inc. between 1979 and 1991. The busiest year on record is 1983, with 6. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 6 |
| 1984 | 5 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 2 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896378 | LYME-CHECK(TM) TEST KIT | LSR | Substantially Equivalent | |
| K903612 | EBV/EA-CHECK TM TEST KIT | LSE | Substantially Equivalent | |
| K891542 | EBNA-CHECK(TM) TEST KIT | LLM | Substantially Equivalent | |
| K890819 | HSV-CHECK(TM) TEST KIT | HIS | Substantially Equivalent | |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | LJN | Substantially Equivalent | |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | GNP | Substantially Equivalent | |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | LJP | Substantially Equivalent | |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | GNP | Substantially Equivalent | |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | GKL | Substantially Equivalent | |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | GKL | Substantially Equivalent | |
| K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 | GKL | Substantially Equivalent | |
| K841809 | COUNT-A-PART PLUS | JPK | Substantially Equivalent | |
| K842140 | PICOSCAL BLOOD CELL COUNTER PS-4 | GKL | Substantially Equivalent | |
| K834372 | PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ | GKL | Substantially Equivalent | |
| K834345 | IM-CHECK | KTN | Substantially Equivalent | |
| K834346 | BHCG-CHECK | JHJ | Substantially Equivalent | |
| K831468 | B HCG-CHECK | JHJ | Substantially Equivalent | |
| K831466 | HCG-CHECK | JHJ | Substantially Equivalent | |
| K831464 | ASO-CHECK | GTQ | Substantially Equivalent | |
| K831467 | RA-CHECK | DHR | Substantially Equivalent | |
| K831465 | CRP-CHECK | DCN | Substantially Equivalent | |
| K831463 | ANA-CHECK | LKJ | Substantially Equivalent | |
| K827289 | DIGITAL RADIOGRAPHY SYSTEM | Substantially Equivalent | ||
| K820037 | SICKLE-CHECK | JCM | Substantially Equivalent | |
| K811063 | LASER-CAL | KRX | Substantially Equivalent | |
| K791772 | COUNTER-CHECK PLUS NORMAL, HIGH ABN. | JPK | Substantially Equivalent | |
| K791750 | COUNTER-CHECK PLUS | JPK | Substantially Equivalent | |
| K790025 | COUNTER CHECK, H001, H002, H003 | KSF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- LJNAntibody Igm, If, Epstein-Barr Virus
- LKJAntinuclear Antibody, Antigen, Control
- GNPAntiserum, Cf, Epstein-Barr Virus
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- KRXCalibrator For Cell Indices
- HISCondom
- JCMControl, Hemoglobin, Abnormal
- GKLCounter, Cell, Automated (Particle Counter)
- LSEEpstein-Barr Virus, Other
- KSFKit, Quality Control For Blood Banking Reagents
- JPKMixture, Hematology Quality Control
- LSRReagent, Borrelia Serological Reagent
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain