FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K Number: K860586
·
Decision May 7, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
28
Review Days
77
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Basic Information
- Device Name
- PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
- K Number
- K860586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Technology, Inc.
- Date Received
- February 19, 1986
- Decision Date
- May 7, 1986
- Product Code
- GKL
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
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Other Clearances by Diagnostic Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896378 | LYME-CHECK(TM) TEST KIT | Nov 5, 1991 | Substantially Equivalent |
| K903612 | EBV/EA-CHECK TM TEST KIT | Oct 16, 1990 | Substantially Equivalent |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K891542 | EBNA-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K890819 | HSV-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Jun 25, 1987 | Substantially Equivalent |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Apr 29, 1987 | Substantially Equivalent |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Nov 28, 1986 | Substantially Equivalent |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | Apr 4, 1986 | Substantially Equivalent |
| K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 | Nov 5, 1985 | Substantially Equivalent |