510(k) K792654
- Device
- CULTURETTE BRAND-PVA/FORMALIN KIT
- Applicant
- MARION LABORATORIES, INC.
- 510(k) number
- K792654
- Product code
- IFQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-24
- Date received
- 1979-12-26
- Regulation
- 864.4010
- Classification name
- Formulations, Mercuric Chloride For Tissue
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1524213
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IFQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792714 | PARA-PAK PVA | Meridian Diagnostics, Inc. | 1980-01-24 |
Legacy Summary#
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FDA Review#
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