IFP — Formalin, Neutral Buffered Class I
FDA product code IFP covers "Formalin, Neutral Buffered", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IFP
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K884755 | donald l. price, ph.d | CONSED FECAL CONCENTRATION SYSTEM | January 10, 1989 |
| K872663 | anatech | DRY-FORM | August 6, 1987 |
| K872140 | medical specialties | (MSI) PATH-SAVER | June 15, 1987 |
| K870852 | anatech | NBF 10% NEUTRAL BUFFERED FORMALIN | March 31, 1987 |
| K853497 | surgipath medical industries | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN | August 28, 1985 |
| K842982 | reagent laboratory | FORMALIN BUFFERED | October 1, 1984 |
| K842940 | anatech | CBA FORMALIN | August 28, 1984 |
| K842728 | e k ind | BUF-FIX | August 3, 1984 |
| K840926 | sigma chemical | FORMALIN SOLUTION 10% NEUTRAL BUFFER | March 12, 1984 |
| K830582 | surgipath medical industries | MILLONIG'S MODIFIED PHOSPHATE BUFFERED | March 17, 1983 |
| K830583 | surgipath medical industries | NEUTRAL BUFFERED FORMALIN 10% | March 17, 1983 |
| K830514 | surgipath medical industries | MILLONIGS MODIFIED PHOSPHATE BUFFERED | March 8, 1983 |
| K812940 | surgipath | 10% NEUTRAL BUFFERED FORMALIN CONCENT | December 10, 1981 |
| K812817 | meridian diagnostics | NEUTRAL DUFFERED FORMA-SCENT | November 10, 1981 |
| K811795 | richard-allan medical ind | 10% NEUTRAL BUFFERED FORMALDEHYDE | July 28, 1981 |