Diagnostic Technology, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 28
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K896378 | LYME-CHECK(TM) TEST KIT | November 5, 1991 |
| K903612 | EBV/EA-CHECK TM TEST KIT | October 16, 1990 |
| K890819 | HSV-CHECK(TM) TEST KIT | June 20, 1989 |
| K891542 | EBNA-CHECK(TM) TEST KIT | June 20, 1989 |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | June 20, 1989 |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | June 25, 1987 |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | April 29, 1987 |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | November 28, 1986 |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | May 7, 1986 |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | April 4, 1986 |
| K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 | November 5, 1985 |
| K841809 | COUNT-A-PART PLUS | November 30, 1984 |
| K842140 | PICOSCAL BLOOD CELL COUNTER PS-4 | August 16, 1984 |
| K834345 | IM-CHECK | February 10, 1984 |
| K834372 | PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ | February 10, 1984 |
| K834346 | BHCG-CHECK | February 4, 1984 |
| K831466 | HCG-CHECK | June 22, 1983 |
| K831468 | B HCG-CHECK | June 22, 1983 |
| K831464 | ASO-CHECK | June 16, 1983 |
| K831467 | RA-CHECK | June 8, 1983 |