IGG — Formaldehyde (Formalin, Formol) Class I
FDA product code IGG covers "Formaldehyde (Formalin, Formol)", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IGG
- 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 |
|---|---|---|---|
| K882268 | anatech | ZINC FORMALIN CONCENTRATE | June 15, 1988 |
| K861201 | surgipath medical industries | FORMALDEHYDE SOLUTION, 37% | April 11, 1986 |
| K811794 | richard-allan medical ind | 37% FORMALDEHYDE | July 28, 1981 |
| K802506 | meridian diagnostics | PLEASCENT OR FORMA-SCENT | November 12, 1980 |
| K792705 | meridian diagnostics | PARA-PAK FORMALIN | January 21, 1980 |
| K792707 | meridian diagnostics | PARA-PAK SAF | January 21, 1980 |
| K771201 | central labs. assoc. md pathologists | FORMALIN BUFFER CONCENTRATE | August 22, 1977 |