← FDA Medical Device Classifications
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
PFG · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1870
Classification
- FDA Product Code
PFG- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 864.1870
- Review panel
- PA
- Medical specialty
- Hematology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown