510(k) K910617
- Device
- NATIVE PROTHROMBIN ANTIGEN EIA
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K910617
- Product code
- DDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-15
- Date received
- 1991-02-12
- Regulation
- 866.5735
- Classification name
- Prothrombin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANN M QUINN
- Address
- 100 Akzo Ave. Durham NC US 27712 27712
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DDF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812985 | AGGLUTEX MORPHINE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 |
Legacy Summary#
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FDA Review#
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