IFPClass I
Formalin, Neutral Buffered
21 CFR 864.4010 / Pathology
IFP is the FDA product code for Formalin, Neutral Buffered, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- IFP
- Device name
- Formalin, Neutral Buffered
- Regulation
- 21 CFR 864.4010
- Device class
- Class I
- Review panel
- Pathology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 15
- Ingested recalls
- 2
Clearances, product code IFP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 1 |
| 1987 | 3 |
| 1989 | 1 |
Applicants with the most clearances
Product code IFP| Applicant | Clearances |
|---|---|
| Surgipath Medical Industries, Inc. | 4 |
| Anatech, Ltd. | 3 |
| Donald L. Price, Ph.D. | 1 |
| E K Ind., Inc. | 1 |
| Medical Specialties Inc. | 1 |
| Meridian Diagnostics, Inc. | 1 |
| Reagent Laboratory, Inc. | 1 |
| Richard-Allan Medical Ind., Inc. | 1 |
| Sigma Chemical Co. | 1 |
| Surgipath | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.