Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Technology, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
190 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896378 | LYME-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1991-11-05 | 729 | 0 |
| K903612 | EBV/EA-CHECK TM TEST KIT | Diagnostic Technology, Inc. | 1990-10-16 | 68 | 0 |
| K891542 | EBNA-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 | 95 | 0 |
| K890819 | HSV-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 | 123 | 0 |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 | 132 | 0 |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Diagnostic Technology, Inc. | 1987-06-25 | 79 | 0 |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Diagnostic Technology, Inc. | 1987-04-29 | 190 | 0 |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Diagnostic Technology, Inc. | 1986-11-28 | 86 | 0 |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | Diagnostic Technology, Inc. | 1986-05-07 | 77 | 0 |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | Diagnostic Technology, Inc. | 1986-04-04 | 77 | 0 |
| K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 | Diagnostic Technology, Inc. | 1985-11-05 | 110 | 0 |
| K841809 | COUNT-A-PART PLUS | Diagnostic Technology, Inc. | 1984-11-30 | 213 | 0 |
| K842140 | PICOSCAL BLOOD CELL COUNTER PS-4 | Diagnostic Technology, Inc. | 1984-08-16 | 78 | 0 |
| K834345 | IM-CHECK | Diagnostic Technology, Inc. | 1984-02-10 | 60 | 0 |
| K834372 | PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ | Diagnostic Technology, Inc. | 1984-02-10 | 71 | 0 |
| K834346 | BHCG-CHECK | Diagnostic Technology, Inc. | 1984-02-04 | 54 | 0 |
| K831468 | B HCG-CHECK | Diagnostic Technology, Inc. | 1983-06-22 | 47 | 0 |
| K831466 | HCG-CHECK | Diagnostic Technology, Inc. | 1983-06-22 | 47 | 0 |
| K831464 | ASO-CHECK | Diagnostic Technology, Inc. | 1983-06-16 | 41 | 0 |
| K831463 | ANA-CHECK | Diagnostic Technology, Inc. | 1983-06-08 | 33 | 0 |
| K831465 | CRP-CHECK | Diagnostic Technology, Inc. | 1983-06-08 | 33 | 0 |
| K831467 | RA-CHECK | Diagnostic Technology, Inc. | 1983-06-08 | 33 | 0 |
| K827289 | DIGITAL RADIOGRAPHY SYSTEM | Diagnostic Technology, Inc. | 1982-04-21 | 22 | 0 |
| K820037 | SICKLE-CHECK | Diagnostic Technology, Inc. | 1982-02-04 | 28 | 0 |
| K811063 | LASER-CAL | Diagnostic Technology, Inc. | 1981-07-01 | 75 | 0 |
| K791772 | COUNTER-CHECK PLUS NORMAL, HIGH ABN. | Diagnostic Technology, Inc. | 1979-10-11 | 34 | 0 |
| K791750 | COUNTER-CHECK PLUS | Diagnostic Technology, Inc. | 1979-10-11 | 36 | 0 |
| K790025 | COUNTER CHECK, H001, H002, H003 | Diagnostic Technology, Inc. | 1979-01-17 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda