Sprays, Synthetic, Smear
Synthetic Smear Sprays are aerosol fixative products used in cytopathology to preserve cells on glass slides immediately after collection, preventing drying artifact in smear preparations such as cervical Pap smears before laboratory processing. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IFI, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IFI
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K803050 | SPRAY, SYNTHETIC SMEAR | Dec 30, 1980 | Substantially Equivalent | Laboratory Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.