510(k) K924892
- Device
- FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K924892
- Product code
- DAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-21
- Date received
- 1992-09-29
- Regulation
- 864.7340
- Classification name
- Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RON SANLYAL
- Address
- 100 Akzo Ave. Durham NC US 27712 27712
Source Documents#
Other 510(k) Records For Product Code DAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K781103 | SPECTRASCAN | Medishield, Inc. | 1978-09-27 |
Legacy Summary#
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FDA Review#
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