Product code IFP
- Device name
- Formalin, Neutral Buffered
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.4010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884755 | CONSED FECAL CONCENTRATION SYSTEM | Donald L. Price, Ph.D. | 1989-01-10 |
| K872663 | DRY-FORM | Anatech, Ltd. | 1987-08-06 |
| K872140 | (MSI) PATH-SAVER | Medical Specialties, Inc. | 1987-06-15 |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | Anatech, Ltd. | 1987-03-31 |
| K853497 | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN | Surgipath Medical Industries, Inc. | 1985-08-28 |
| K842982 | FORMALIN BUFFERED | Reagent Laboratory, Inc. | 1984-10-01 |
| K842940 | CBA FORMALIN | Anatech, Ltd. | 1984-08-28 |
| K842728 | BUF-FIX | E K Ind., Inc. | 1984-08-03 |
| K840926 | FORMALIN SOLUTION 10% NEUTRAL BUFFER | Sigma Chemical Co. | 1984-03-12 |
| K830582 | MILLONIG'S MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | 1983-03-17 |
| K830583 | NEUTRAL BUFFERED FORMALIN 10% | Surgipath Medical Industries, Inc. | 1983-03-17 |
| K830514 | MILLONIGS MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | 1983-03-08 |
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Surgipath | 1981-12-10 |
| K812817 | NEUTRAL DUFFERED FORMA-SCENT | Meridian Diagnostics, Inc. | 1981-11-10 |
| K811795 | 10% NEUTRAL BUFFERED FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10849832020360 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832025676 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832024396 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832024112 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832024105 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832023092 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832020695 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832020350 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832026904 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832024368 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832024306 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832024153 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832024122 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832022968 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 10849832018619 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 20849832020343 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-13 |
| 00849832023036 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-12 |
| 00849832023043 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-12 |
| 00849832023050 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2026-10-12 |
| 00613647018859 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00613647018842 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| M445891201 | Formalin / C&S / Clean Stool Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445892021 | Total-Fix / Formalin / C&S / Clean O&P Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445892031 | Z-PVA / Formalin / C&S / Clean O&P Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891031 | O&P Collection Vials Zinc PVA / Formalin / C&S Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445890211 | O&P Collection Vials Formalin/C&S Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| 20885380166775 | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC | 2018-10-03 |
| 20885380166782 | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC | 2018-10-03 |
| 10885380131783 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-07-14 |
| 10885380131806 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-07-14 |