Product Code: GRO
FDA class 2
21 CFR 866.3300
Antisera, Fluorescent, All Types, Hemophilus Spp.
Microbiology
The Antisera, Fluorescent, All Types, Hemophilus Spp. consists of fluorescent antisera used in immunofluorescence assays to detect and identify Haemophilus species in clinical laboratory specimens. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GRO, regulated under 21 CFR 866.3300 in the Microbiology specialty. No special flags apply to this device.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
5
Basic Information
- Product Code
- GRO
- Device Class
- FDA class 2
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K851271 | LEGIONELLA CULTURE CONFIRMATIN KIT | Jul 08, 1985 | Substantially Equivalent | GEN-PROBE, INC. |
| K834067 | LEGIONELLA DIFFERENTIATION DISK | Jan 03, 1984 | Substantially Equivalent | REMEL CO. |
| K802423 | PHADEBACT HAEMOPHILUS TEST | Nov 12, 1980 | Substantially Equivalent | PHARMACIA, INC. |
| K800493 | BACTOGEN-H. INFLUENZAE TYPE B | Apr 04, 1980 | Substantially Equivalent | ARMKEL, LLC. |