PARA-PAK FORMALIN
FDA 510(k) clearance K792705 · decided 1980-01-21
Clearance details
- K-number
- K792705
- Device name
- PARA-PAK FORMALIN
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-27
- Decision date
- 1980-01-21
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- IGG
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZINC FORMALIN CONCENTRATE (K882268) | Anatech, Ltd. | 1988-06-15 |
| FORMALDEHYDE SOLUTION, 37% (K861201) | Surgipath Medical Industries, Inc. | 1986-04-11 |
| 37% FORMALDEHYDE (K811794) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| PLEASCENT OR FORMA-SCENT (K802506) | Meridian Diagnostics, Inc. | 1980-11-12 |
| PARA-PAK SAF (K792707) | Meridian Diagnostics, Inc. | 1980-01-21 |
| FORMALIN BUFFER CONCENTRATE (K771201) | Central Labs. Assoc. MD Pathologists | 1977-08-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and recall (Z-0520-2024) | Meridian Bioscience Inc | 2023-12-08 |