ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
FDA 510(k) clearance K890633 · decided 1989-04-21
Clearance details
- K-number
- K890633
- Device name
- ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-08
- Decision date
- 1989-04-21
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LCO
- Device class
- 2
- Regulation number
- 864.7695
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HemosIL CL HIT-IgG(PF4-H) (K243374) | Instrumentation Laboratory (IL) Co. | 2025-01-28 |
| PF4 Enhanced assay (K201570) | Immucor Gti Diagnostics, Inc. | 2020-09-11 |
| PF4 IgG assay (K201311) | Immucor Gti Diagnostics, Inc. | 2020-06-18 |
| HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (K170854) | Instrumentation Laboratory CO | 2017-09-08 |
| HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (K153137) | Instrumentation Laboratory CO | 2016-07-08 |
| PF4 IGG (K071781) | Genetic Testing Institute | 2007-12-19 |
| ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (K071255) | Hyphen Biomed | 2007-09-07 |
| PF4 ENHANCED SOLID PHASE ELISA (K053559) | Genetic Testing Institute | 2006-01-20 |
| HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (K040293) | Akers Laboratories, Inc. | 2004-05-28 |
| ASSERACHROM HPIA TEST KIT (K003767) | Diagnostica Stago, Inc. | 2001-02-12 |
| GTI-PF4 ELISA (K983379) | Genetic Testing Institute | 1999-03-09 |
| ASSERACHROM PF4 KIT (K862774) | American Bioproducts Co. | 1986-09-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |