510(k) K010328
- Device
- MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
- Applicant
- Izon Business Products, Inc.
- 510(k) number
- K010328
- Product code
- PJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-09
- Date received
- 2001-02-02
- Regulation
- 862.1675
- Classification name
- Blood/Plasma Collection Device For Dna Testing
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JACK WERTZ
- Address
- 520 W. Nyack Rd. West Nyack NY US 10994 10994
FDA Registration Numbers#
- 3013517171
- 1917413
- 3009732568
- 3010370650
- 1423537
- 3005674478
- 3005202328
- 2243072
- 3013557562
- 1125230
- 9617032
- 9617475
- 1036836
- 3003744503
- 1058584
- 8020040
- 3006191977
- 9613662
Source Documents#
510(k) summary PDF not indicated by FDA
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| K031359 | S-MONOVETTE EDTA K2-GEL | Sarstedt, Inc. | 2003-09-12 |
| K014104 | VACUETTE EDTA K2 TUBES | Greiner Vacuette North America, Inc. | 2002-02-01 |
| K012043 | VACUETTE EDTA K2 GEL TUBES | Greiner Vacuette North America, Inc. | 2001-09-24 |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Becton Dickinson Vacutainer Systems | 1998-02-24 |