510(k) K864893
- Device
- ANTI-CYTOKERATIN MONOCLONAL ANTIBODY
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K864893
- Product code
- LYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-07
- Date received
- 1986-12-15
- Regulation
- 866.5550
- Classification name
- Cytokeratins
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3027394506
- 3008352382
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LYE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881259 | MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL | Triton Biosciences, Inc. | 1988-10-12 |
Legacy Summary#
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FDA Review#
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