FDA PMA
FDA Unclassified
Approved (Withdrawn)
🇺🇸 United States
Dna-Probe, Human Chromosome
PMA: P880045
·
Decision Oct 3, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Dna-Probe, Human Chromosome
- Trade Name
- OSI TRANSPROBE-1
- PMA Number
- P880045
- Device Class
- FDA Unclassified
- Product Code
- MAO
- Generic Name
- DNA-probe, human chromosome
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 3, 1989
- Date Received
- June 21, 1988
- Expedited Review
- N
- Docket Number
- 89M-0457
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAO | Dna-Probe, Human Chromosome | FDA unclassified | Unknown |