510(k) K911434
- Device
- THROMBONOSTIKA F1.2
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K911434
- Product code
- MIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-10-31
- Date received
- 1991-04-02
- Regulation
- 864.7320
- Classification name
- Prothrombin Fragment 1.2
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS S CLEMENT
- Address
- 100 Akzo Ave. Durham NC US 27712 27712
FDA Registration Numbers#
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | Dade Behring, Inc. | 2004-12-10 |
| K964934 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | 1997-03-18 |
| K962176 | TPP | Panbio, Inc. | 1996-10-18 |
| K922934 | ENZYGNOST F 1+2 | Behring Diagnostics, Inc. | 1992-11-16 |
| K920895 | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | Baxter Diagnostics, Inc. | 1992-06-04 |
Legacy Summary#
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FDA Review#
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