510(k) K983379
- Device
- GTI-PF4 ELISA
- Applicant
- GENETIC TESTING INSTITUTE
- 510(k) number
- K983379
- Product code
- LCO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-09
- Date received
- 1998-09-25
- Regulation
- 864.7695
- Classification name
- Platelet Factor 4 Radioimmunoassay
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL MOGHADDAM
- Address
- 150 N. Patrick Blvd. Suite 100 Brookfield WI US 53045 53045
FDA Registration Numbers#
- 3004434070
- 3037000637
- 9610746
- 2183608
- 9710666
- 1217183
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | 2025-01-28 |
| K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | 2020-09-11 |
| K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | 2020-06-18 |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017-09-08 |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory CO | 2016-07-08 |
| K071781 | PF4 IGG | Genetic Testing Institute | 2007-12-19 |
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Hyphen Biomed | 2007-09-07 |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | Genetic Testing Institute | 2006-01-20 |
| K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | Akers Laboratories, Inc. | 2004-05-28 |
| K003767 | ASSERACHROM HPIA TEST KIT | Diagnostica Stago, Inc. | 2001-02-12 |
| K890633 | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | Behring Diagnostics, Inc. | 1989-04-21 |
| K862774 | ASSERACHROM PF4 KIT | American Bioproducts Co. | 1986-09-04 |
Legacy Summary#
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FDA Review#
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